Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
MBrace Therapeutics
Study ID
NCT07145255
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • Colo-rectal Cancer
  • Lung Cancer (Non-Small Cell)
  • Pancreas Cancer, Duct Cell Adenocarcinoma
  • Prostate Cancer Castration-resistant Prostate Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADC — DRUG
    MBRC-201 ADC

Study Details

This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.

Key Dates

Start date
Sep 3, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a
    Dose Escalation
  • Experimental: Phase 1b
    Dose Expansion
  • Experimental: Phase 2
    Recommended Phase 2 Dose

Primary Outcome Measure

Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) [ Time Frame: From Enrollment through treatment and long term follow-up (approximately 24 months) ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Lam Phu
[email protected]
415-613-2945
Rauhl Aggarwal, MD (PRINCIPAL_INVESTIGATOR)
START, MidwestGrand RapidsMichigan49546
Manish R Sharma, MD
[email protected]
6163891824
Abigail VanKirk
616-389-1810
START, AsteraEast BrunswickNew Jersey08816
Laura Sullivan
[email protected]
732-426-4751
Bruno S Fang, MD (PRINCIPAL_INVESTIGATOR)
NEXT, DallasIrvingTexas75039
Michael M Song, MD
[email protected]
(972) 893-8800
Mofopefoluwa Akinwale
START San AntonioSan AntonioTexas78229
Kyruakos P Papadopoulos, MD
[email protected]
2105935265
Isabel Jimenez, RN
[email protected]
210-593-5265
START, Mountain RegionWest Valley CityUtah84119
William B McKean, MD, PhD
[email protected]
801-907-4750
Marie Asay
[email protected]
801-907-4770
NEXT, VirginiaFairfaxVirginia22031
Mohamad A Salkeni, MD
[email protected]
7037834518
Maybelle De La Rosa

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CASTART, Midwest· Grand Rapids, MISTART, Astera· East Brunswick, NJNEXT, Dallas· Irving, TXSTART San Antonio· San Antonio, TXSTART, Mountain Region· West Valley City, UT

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