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MSC-1

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Apr 5, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

MSC-1 · 1 trial · 4 indications

Phase 1 1
NCT03490669Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid TumorsAdvanced Solid Tumors
COMPLETED41 Analytics
PHASE1COMPLETED
Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study
Patients will be evaluated for approximately 6 months or until disease progression

Assessment of frequency \& severity of adverse events

Assess the preliminary anti-tumor activity of MSC-1 monotherapy
Patients will be evaluated for approximately 6 months or until disease progression

Determine objective response rate (ORR)

Secondary Endpoints

Confirm safest dose of MSC-1 for further study
Patients will be evaluated for approximately 6 months or until disease progression
Characterize the PK of MSC-1
Patients will be evaluated before and after each dose of MSC-1 for approximately 6 months or until disease progression. PK will be evaluated more frequently for the first 2 cycles of treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALMultiple dose levels of MSC-1 treatment once every 3 weeks
Dose ExpansionEXPERIMENTALMSC-1 treatment at the recommended Phase 2 dose once every 3 weeks

Interventions

NameTypeDescription
MSC-1BIOLOGICALhumanized monoclonal antibody for intravenous administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria (All patients): * Confirmed Advanced Unresectable Solid Tumor * Measurable disease by RECIST 1.1 by CT or MRI * Documented disease progression on or following last line of therapy * Archival tumor sample for submission * ECOG performance status 0 or 1 * Resolution of all acute, r...

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

Frequently asked questions about MSC-1

What is MSC-1 used for?

MSC-1 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors, including pancreatic cancer, non-small cell lung cancer, and ovarian cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does MSC-1 target?

MSC-1 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity in patients with advanced solid tumors.

Who makes MSC-1?

MSC-1 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential in treating advanced solid tumors.

What phase is MSC-1 in?

MSC-1 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received FDA approval and is still undergoing clinical evaluation for safety and efficacy in patients with advanced solid tumors.

What clinical trials is MSC-1 in?

MSC-1 has been studied in one clinical trial, identified as NCT03490669, which was a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MSC-1 in patients with advanced solid tumors. The trial was completed and enrolled 41 participants.