A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

Conditions

• Advanced/Metastatic Solid Tumors
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer
• HNSCC
• Head and Neck Squamous Cell Carcinoma
• NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MCLA-158 — DRUG
  full-length IgG1 bispecific antibody targeting EGFR and LGR5
• MCLA-158 + Pembrolizumab — COMBINATION_PRODUCT
  MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.
• MCLA-158 + FOLFIRI — COMBINATION_PRODUCT
  MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.
• MCLA-158 + FOLFOX — COMBINATION_PRODUCT
  MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.

Study Details

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.

Key Dates

Start date

May 2, 2018

Status verified

Jan 2025

Primary completion

Nov 30, 2025

Completion

Nov 30, 2027

Study Design

Enrollment

523 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MCLA-158
  In Part 1, the dose escalation phase, patients with metastatic CRC will receive escalating doses of MCLA-158 (every 2 weeks) until MTD or RP2D is reached. Each Cycle is 28 days. Single agent treatment. In Part 2, the expansion phase, participants with metastatic CRC and certain other solid tumors will receive intravenous infusion of MCLA-158 at the recommended Phase II dose (RP2D) every 2 weeks, at Day 1 and Day 15. The duration of each treatment cycle is 28 days. In addition, in the expansion phase, one randomized cohort will evaluate 2 doses (1100 mg and 1500 mg) of MCLA-158 in head and neck squamous cell carcinoma patients.
• Experimental: MCLA-158 + Pembrolizumab
  MCLA-158 in combination with pembrolizumab will be explored first in head and neck squamous cell carcinoma patients eligible to receive pembrolizumab as first-line monotherapy.
• Experimental: MCLA-158 + FOLFIRI combination chemotherapy
  MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.
• Experimental: MCLA-158 + FOLFOX combination chemotherapy
  MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.

Primary Outcome Measure

Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1 [ Time Frame: 4 weeks ]

Central Contacts

• Gianluca Laus, MD
  +31 85 016 2500
  [email protected]
• Ernesto Wasserman, MD
  +1 617 401 4499
  [email protected]

Locations (23)

Find similar trials in La Jolla, CA

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