Trial Outcomes & Findings for MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (NCT NCT06227546)

Last Updated: 2026-04-13

Results Overview

Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to\<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2026-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	MCG018 MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MCG018 MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Overall Study Withdrawal by Subject	1

Baseline Characteristics

MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MCG018 n=9 Participants MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Age, Customized 18-69 years old	5 Participants n=193 Participants
Age, Customized > 69 years old	4 Participants n=193 Participants
Sex: Female, Male Female	4 Participants n=193 Participants
Sex: Female, Male Male	5 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	0 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	2 Participants n=193 Participants
Race (NIH/OMB) White	7 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	MCG018 n=9 Participants MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Objective Response Rate (ORR)	0 Participants

SECONDARY outcome

Timeframe: from start of treatment through 60 days after last treatment, approximately 1 year

Number of participants with Investigator assessed treatment emergent adverse events per Common terminology criteria for adverse effects (CTCAE) version 5.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Defined as the time from response to disease progression or death in patients who achieve complete or partial response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Defined as time from study drug initiation to death as assessed using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

Adverse Events

MCG018

Serious events: 4 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	MCG018 n=9 participants at risk MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Cardiac disorders Atrial fibrillation	33.3% 3/9 • Number of events 4 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Infections and infestations Lung infection	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Creatinine increased	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Vascular disorders Hypotension	11.1% 1/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.

Other adverse events

Other adverse events
Measure	MCG018 n=9 participants at risk MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Blood and lymphatic system disorders Anemia	33.3% 3/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Cardiac disorders Sinus tachycardia	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Eye disorders Blurred vision	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Eye disorders Eye disorders - Other, specify	11.1% 1/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Eye disorders Periorbital edema	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Gastrointestinal disorders Oral pain	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
General disorders Edema limbs	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
General disorders Facial pain	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
General disorders Fatigue	55.6% 5/9 • Number of events 6 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
General disorders Non-cardiac chest pain	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Infections and infestations Conjunctivitis	33.3% 3/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Infections and infestations Thrush	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Immune system disorders Upper respiratory infection	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Creatinine increased	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Lymphocyte count decreased	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Neutrophil count decreased	33.3% 3/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Platelet count decreased	33.3% 3/9 • Number of events 4 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Investigations Weight loss	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Metabolism and nutrition disorders Anorexia	44.4% 4/9 • Number of events 5 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Metabolism and nutrition disorders Hypophosphatemia	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Nervous system disorders Dysgeusia	11.1% 1/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Nervous system disorders Memory impairment	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	11.1% 1/9 • Number of events 1 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Skin and subcutaneous tissue disorders Rash acneiform	22.2% 2/9 • Number of events 2 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Number of events 3 • Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.

Additional Information

Chul Kim, MD, MPH

Georgetown University

Phone: 202-444-2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place