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AMG 650 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Volastra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new drug called AMG 650 in adults to see if it is safe and to find the best dose for future studies.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Exploration PhaseExperimental Treatment1 Intervention
Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD.
Group II: Dose Expansion Phase Group 2: HGSOCExperimental Treatment1 Intervention
Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
Group III: Dose Expansion Phase Group 1: TNBCExperimental Treatment1 Intervention
Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 650
2020
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Volastra Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
240 Total Patients Enrolled
AmgenIndustry Sponsor
1,420 Previous Clinical Trials
1,382,884 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,799 Total Patients Enrolled
~12 spots leftby Sep 2025
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