Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (petosemtamab) as single agent or in combination in advanced solid tumors

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513627-16-01

Acronym

MCLA-158-CL01

Enrollment

395

Registered

2024-10-22

Start date

2018-03-28

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer metastatic, Malignant solid tumor

Brief summary

Objective Response Rate (ORR), Frequency and severity of adverse events, serious adverse events, treatment discontinuations and modifications

Detailed description

Pharmacokinetic parameters (CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2,) and population pharmacokinetics, Progression-Free Survival (PFS) and Duration of Response (DOR), Overall Survival (OS)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGOXALIPLATIN

DRUGFLUOROURACIL

DRUGCALCIUM FOLINATE

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR), Frequency and severity of adverse events, serious adverse events, treatment discontinuations and modifications	—

Secondary

Measure	Time frame
Pharmacokinetic parameters (CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2,) and population pharmacokinetics, Progression-Free Survival (PFS) and Duration of Response (DOR), Overall Survival (OS)	—

Countries

Belgium, France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026