A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT03526835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03526835
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 560 participants
Conditions and interventions
Conditions
Interventions
- MCLA-158 Drug
- MCLA-158 + Pembrolizumab Combination Product
- MCLA-158 + FOLFIRI Combination Product
- MCLA-158 + FOLFOX Combination Product
Drug · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2018
- Primary completion
- Apr 30, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Jul 28, 2026
2018 – 2028
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD | La Jolla | California | 92093 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Active, not recruiting |
| Sharp Healthcare | San Diego | California | 92123 | Recruiting |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | Active, not recruiting |
| University of Florida | Gainesville | Florida | 32610 | Recruiting |
| Sarah Cannon Research Institute (Lake Nona) | Orlando | Florida | 32827 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Massachusetts General Hospital - Dana Farber | Boston | Massachusetts | 02114 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Completed |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | Completed |
| Washington University School of Medicine at St Louis | St Louis | Missouri | 63110 | Recruiting |
| Cayuga Medical Center | Ithaca | New York | 14850 | Recruiting |
| Mt. Sinai | New York | New York | 10029 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Hematology-Oncology Associates of Central New York | Syracuse | New York | 13057 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State University | Columbus | Ohio | 43221 | Recruiting |
| Taylor Cancer Research Center | Maumee | Ohio | 43537 | Recruiting |
| SSM OKC Hightower Clinical | Oklahoma City | Oklahoma | 73102 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| The University Of Tennessee Health Science Center | Memphis | Tennessee | 38103 | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Completed |
| Texas Oncology | Dallas | Texas | 75246 | Recruiting |
| Oncology Consultants | Houston | Texas | 77030 | Recruiting |
| Texas Oncology | Tyler | Texas | 75702 | Recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | Recruiting |
| University of Utah Health Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | Recruiting |
| Georgetown University Medical Center | Georgetown | Washington | 20007 | Recruiting |
| Cancer Care Northwest | Spokane | Washington | 99202 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03526835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03526835 live on ClinicalTrials.gov.