Trial Outcomes & Findings for Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas (NCT NCT03808558)
NCT ID: NCT03808558
Last Updated: 2026-05-22
Results Overview
Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
ACTIVE_NOT_RECRUITING
PHASE2
18 participants
every 8 weeks through study completion, an average of 1 year
2026-05-22
Participant Flow
Participant milestones
| Measure |
TVB-2640
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
Baseline characteristics by cohort
| Measure |
TVB-2640
n=18 Participants
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=2 Participants
|
|
Age, Continuous
|
67 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=2 Participants
|
|
Smoking History
Former smoker
|
13 Participants
n=2 Participants
|
|
Smoking History
Never smoker
|
5 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: every 8 weeks through study completion, an average of 1 yearDetermine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
TVB-2640
n=18 Participants
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Disease Control Rate of TVB-2640
|
16 Participants
|
PRIMARY outcome
Timeframe: every 8 weeks through study completion, an average of 1 yearDetermine response rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
TVB-2640
n=18 Participants
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Response Rate of TVB-2640
Partial Disease
|
9 Participants
|
|
Response Rate of TVB-2640
Stable Disease
|
7 Participants
|
|
Response Rate of TVB-2640
Unknown Outcome
|
2 Participants
|
SECONDARY outcome
Timeframe: Pretreatment and four weeks of treatment.Secondary endpoints are 11C-acetate tumor uptake pretreatment and at four weeks of treatment and plasma lipidomics pretreatment and at four weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pretreatment and four weeks of treatment.To establish the predictive value of 11C-acetate PET pretreatment and post-treatment tumor uptake for disease control rate and response rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pretreatment and four weeks of treatment.Blood samples for fasting plasma lipidomics will be collected at baseline and four weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pretreatment and four weeks of treatment.Sebutabe collection of sebaceous secretion of fatty acids will be performed at baseline and four weeks of treatment
Outcome measures
Outcome data not reported
Adverse Events
TVB-2640
Serious adverse events
| Measure |
TVB-2640
n=18 participants at risk
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Nervous system disorders
Transient Ischemic Attack
|
5.6%
1/18 • Number of events 2 • 4 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain (Hip and Pelvic)
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
5.6%
1/18 • Number of events 2 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Psychiatric disorders
Altered Mental Status
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 2 • 4 years, 6 months
|
|
Injury, poisoning and procedural complications
Concussion
|
5.6%
1/18 • Number of events 2 • 4 years, 6 months
|
|
Infections and infestations
COVID-19 Infection
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
General disorders
Disease progression
|
27.8%
5/18 • Number of events 5 • 4 years, 6 months
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Number of events 2 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Number of events 3 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Eye disorders
Retinal Tear
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
Other adverse events
| Measure |
TVB-2640
n=18 participants at risk
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640: TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Gastrointestinal disorders
Mucositis / Aphthous ulcer
|
22.2%
4/18 • Number of events 4 • 4 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 4 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
22.2%
4/18 • Number of events 4 • 4 years, 6 months
|
|
Nervous system disorders
Peripheral neuropathy
|
22.2%
4/18 • Number of events 4 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin desquamation / peeling
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Slow wound healing
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Eye disorders
Watering eyes
|
16.7%
3/18 • Number of events 3 • 4 years, 6 months
|
|
Gastrointestinal disorders
Xerostomia
|
50.0%
9/18 • Number of events 9 • 4 years, 6 months
|
|
General disorders
Fatigue
|
38.9%
7/18 • Number of events 7 • 4 years, 6 months
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • 4 years, 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.8%
5/18 • Number of events 5 • 4 years, 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
2/18 • Number of events 2 • 4 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Eye disorders
Blurred vision / vision changes
|
22.2%
4/18 • Number of events 4 • 4 years, 6 months
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 3 • 4 years, 6 months
|
|
Eye disorders
Corneal abrasion / epithelial erosion
|
11.1%
2/18 • Number of events 2 • 4 years, 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite / Anorexia
|
16.7%
3/18 • Number of events 3 • 4 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
3/18 • Number of events 3 • 4 years, 6 months
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Eye disorders
Dry eye
|
27.8%
5/18 • Number of events 5 • 4 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
44.4%
8/18 • Number of events 8 • 4 years, 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Number of events 1 • 4 years, 6 months
|
Additional Information
Dr. David Gerber
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place