At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed solid tumors with metastatic or locally advanced disease not amenable to curative standard therapy
- ✓Baseline fresh tumor sample (FFPE) from metastatic or primary site
- ✓Amenable for biopsy (if safe/feasible)
- ✓Measurable disease by RECIST version 1.1
- ✕Untreated or symptomatic CNS metastases, or requiring radiation/surgery/steroids within 14 days of entry
- ✕Known leptomeningeal involvement
- ✕Participation in another clinical study or investigational drug within 4 weeks prior to entry
- ✕Prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever shorter); 6 weeks for cytotoxic/immunotherapy with major delayed toxicity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03526835Phase 2RecruitingUpdate OverdueUpdated 17mo ago · Completion was 7mo agoPhase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating MCLA-158, MCLA-158 + Pembrolizumab, and 2 other interventions for Advanced/Metastatic Solid Tumors and 7 related conditions. Currently recruiting, targeting 523 participants across 45 sites in 6 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
full-length IgG1 bispecific antibody targeting EGFR and LGR5
MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.
MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.
MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.