All Drugs and Chemicals

Immunomodulating Agents

The starting dose is 0.03 mg/kg every 3 weeks (q3w) and up to 6 dose levels are planned.

Study treatment will be administered as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first.

The starting dose is 0,5 mg/kg every week (q1w) and up to 3 dose levels are planned.

Study treatment will be administered as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first.

The study will start with dose-escalation cohorts to determine the recommended dose for expansion (RDE) or the maximum tolerated dose (MTD).

Once the RDE (or MTD) has been determined, a safety expansion cohort will be opened and additional patients will be treated with MP0317 monotherapy at this dose to confirm safety in a larger population.

Study treatment will be administered every 3 weeks (q3w) as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first. Treatment beyond PD will be allowed as per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST).

MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q3w regimen)

The study will start with dose-escalation cohorts to determine the recommended dose for expansion (RDE) or the maximum tolerated dose (MTD).

Once the RDE (or MTD) has been determined, a safety expansion cohort will be opened and additional patients will be treated with MP0317 monotherapy at this dose to confirm safety in a larger population.

Study treatment will be administered every week (q1w) as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first. Treatment beyond PD will be allowed as per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST).

MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q1w regimen)

This study is investigating a new experimental therapy, MP0317, a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40. Preclinical studies suggest that MP0317 may provide benefit for the treatment of tumors known to express high levels of FAP and for which approved therapies have been exhausted. This is the first study of MP0317 in humans and its main purpose is to test its safety and tolerability in patients with advanced solid tumors. This study will also examine the blood levels of MP0317 at several increasing dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity.

First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

A Phase 1, First-in-human, Multicenter, Open-label, Dose-escalation Study to Characterize the Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

DLTs will be reviewed as a subset of AEs that occur within 4 weeks after first study drug administration

Based on occurrence of DLTs within an adaptive study design following Bayesian Logistic Regression Model (BLRM)

Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and SAEs

Including parameters like maximum serum concentration (Cmax), time at Cmax (Tmax), minimal serum concentration (Cmin)

Proportion of participants with complete response (CR) and partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Best overall response (BOR) of CR, PR or stable disease (SD) lasting 4 or more weeks following first study drug administration

For participants with CR or PR, DOR will be calculated as the time from CR or PR to progressive disease (PD) or death.

Time from first study drug administration to PD

Time from first study drug administration to PD or death

Time from first study drug administration to death of any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors	NCT05098405	Advanced Malign...	MP0317, a tri-s... MP0317, a tri-s...	18 Years -	Molecular Partners AG
First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors	NCT05098405	Advanced Malign...	MP0317, a tri-s... MP0317, a tri-s...	18 Years -	Molecular Partners AG

Spots Global Cancer Trial Database for relapsed malignant solid neoplasm