Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: MP0310
- Registration Number
- NCT04049903
- Lead Sponsor
- Molecular Partners AG
- Brief Summary
To evaluate the safety and tolerability of MP0310, a DARPin® therapeutic candidate for tumor targeted activation of T cells, in patients with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MP0310 Part A MP0310 Enrollment will follow a standard 3 + 3 dose escalation design. Sequential Cohorts of patients will be dosed until the MTD or unacceptable toxicity is reached. Up to 12 additional patients in total may be included at selected dose levels (up to 3). MP0310 Part B MP0310 weekly schedule, at least 3 and up to 24 patients evaluable for DLT assessment will be enrolled (1 to 4 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)). MP0310 Part C MP0310 q3w schedule implementing B-cell depletion, at least 3 and up to 12 patients evaluable for DLT assessment will be enrolled (1 to 2 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)).
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) or a tolerated dose below MTD (if MTD is not reached) From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy. Based on occurrence of DLTs within a 3+3 clinical trial design
Recommended expansion dose (RED) From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy. Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and serious adverse events (SAEs)
Incidence of Adverse Events (AEs) From signing of informed consent form (ICF) until 10 weeks following the last dose or start of new anticancer therapy. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Incidence of dose-limiting toxicities (DLTs) First 21 days of dosing. Dose-limiting toxicities will be reviewed as a subset of AEs that occur within the first 21 days of dosing and meet the protocol-specified criteria.
- Secondary Outcome Measures
Name Time Method Total clearance (CL) 24 months PK analysis of MP0310
Serum concentration - time profiles 24 months Including parameters like maximal serum concentration (Cmax), time at Cmax (Tmax), minimal serum concentration (Cmin)
Area under the serum concentration-time curve (AUC) 24 months Pharmacokinetic (PK) analysis of MP0310
Terminal elimination half-life (t1/2) 24 months PK analysis of MP0310
Accumulation ratio 24 months PK analysis of MP0310
Incidence of anti-drug-antibodies 24 months Serum concentration-time profile of anti-drug antibodies
Objective response rate (ORR) 24 months The proportion of participants with confirmed 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)
Disease control rate (DCR) 24 months Stable disease lasting 4 or more weeks following the initiation of MP0310
Duration of response (DoR) 24 months For participants with CR or PR, DOR will be calculated as time from initial response of CR or PR to progressive disease or death.
Volume of distribution (Vd), volume at steady state (Vss) 24 months PK analysis of MP0310
Trial Locations
- Locations (3)
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Claudius Regaud; Institut Universitaire du Cancer Toulouse Oncopole (IUCT-O)
🇫🇷Toulouse, France