Trial · NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
NCT03526835, Phase 1, Phase 2, Recruiting, Genmab
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors. Trials, record NCT03526835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03526835
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
- NCT number
- NCT03526835
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 560 participants, estimated
- Lead sponsor
- Genmab
- Conditions
- Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, NSCLC, HNSCC, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer
- Interventions
- MCLA-158, MCLA-158 + Pembrolizumab, MCLA-158 + FOLFIRI, MCLA-158 + FOLFOX
- First posted
- 2018-05-16
- Last updated
- 2026-11-02
- Other registries' IDs
- eudract:2017-004745-24
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1 | 4 weeks | Evaluation of the number and severity of participants with treatment related toxicities observed during the dose escalation. |
| Primary | Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer, and combination cohorts): Safety and tolerability: AEs and SAEs | 6-12 months | Incidence, severity, and relationship of AEs and SAEs |
| Primary | Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Treatment discontinuations and dose modifications due to AEs | 6-12 months | Treatment discontinuations due to AEs and dose modifications due to AEs |
| Primary | Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): Best overall response (BOR) | 36 months | Evaluation of clinical benefit assessed by RECIST v1.1 determining Best overall response (BOR) |
| Primary | Expansion (Single agent - non-randomized, and combination cohorts): Objective response rate (ORR) | 36 months | Evaluation of clinical benefit assessed by RECIST v1.1 determining objective response rate (ORR) |
| Primary | Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg: TEAEs | 8 weeks | Incidence of TEAEs at Week 8 |
| Primary | Expansion: (subcutaneous cohort): Bioavailability of subcutaneous vs intravenous administration | 6 weeks | Bioavailability of subcutaneous vs intravenous administration |
| Primary | Expansion: (subcutaneous cohort): Area under the concentration versus time curve from time zero to time t [AUC0-t] | 6 weeks | Area under the concentration versus time curve from time zero to time t \[AUC0-t\] |
| Primary | Expansion: (subcutaneous cohort): Maximum plasma concentration [Cmax] | 8 weeks | Maximum plasma concentration as measured from all individual plasma concentrations |
| Primary | Expansion: (subcutaneous cohort): Minimum plasma drug concentration [Ctrough] | 6 weeks | Minimum plasma concentration as measured from all individual plasma concentrations |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03526835
GET https://conductscience.org/api/trials/v1/NCT03526835/registered?page=2