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MP0310

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Molecular Partners AG|Last Updated: Dec 22, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

MP0310 · 1 trial · 1 indication

Phase 1 1
NCT04049903Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid TumorsAdvanced Solid Tumor
COMPLETED38 Analytics
PHASE1COMPLETED
Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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)

Secondary Endpoints

Serum concentration - time profiles
24 months
Area under the serum concentration-time curve (AUC)
24 months
Total clearance (CL)
24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MP0310 Part AEXPERIMENTALEnrollment 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 BEXPERIMENTALweekly 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 CEXPERIMENTALq3w 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)).

Interventions

NameTypeDescription
MP0310DRUGMP0310 will be examined for safety, tolerability, PK, and PD activity in subjects with advanced solid tumors
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Patient has an advanced, histologically-proven solid tumor of one of the following types, treated with at least one line of systemic therapy, and for which approved therapies have been exhausted or for which the Investigator considers the patient ineligible or intolerant of o...

Countries:France
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about MP0310

What is MP0310 used for?

MP0310 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, blood levels, and activity in patients with advanced solid tumors.

Who makes MP0310?

MP0310 is being developed by Molecular Partners AG, a biopharmaceutical company. The company's stock is traded under the ticker symbol MOLN. The drug is currently in Phase 1 clinical development for the treatment of advanced solid tumors.

What phase is MP0310 in?

MP0310 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to investigate the safety, blood levels, and activity of MP0310 in patients with advanced solid tumors.

What clinical trials is MP0310 in?

MP0310 has one completed clinical trial with the identifier NCT04049903. This Phase 1 study investigated the safety, blood levels, and activity of MP0310 in patients with advanced solid tumors. The trial enrolled 38 participants and was conducted in France.

Is MP0310 FDA approved?

MP0310 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of advanced solid tumors. The drug is being studied for its safety, blood levels, and activity, but has not yet received regulatory approval.