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Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

NCT04641871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-06-26

No results posted yet for this study

Summary

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

Conditions

Interventions

DRUG

Sym021

IV infusion over 30 minutes on day 1 and 15 of each cycle.

DRUG

Sym022

IV infusion over 30 minutes on day 1 and 15 of each cycle.

DRUG

Sym023

IV infusion over 30 minutes on day 1 and 15 of each cycle.

DRUG

Irinotecan Hydrochloride

IV infusion over 90 min on day 1 and 15 of the first 2 cycles. After 2 cycles of treatment, irinotecan may be discontinued at the Investigator's discretion

Sponsors & Collaborators

  • Symphogen A/S

    lead INDUSTRY

Principal Investigators

  • Nehal Lakhani, MD · START Midwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2024-06-03
Completion
2024-06-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641871 on ClinicalTrials.gov