A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Apollo Therapeutics Ltd
Study ID
NCT06399757
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • APL-5125 — DRUG
    APL-5125 is an oral drug (capsule) taken daily in 28-day cycles

Study Details

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).

Key Dates

Start date
Jun 18, 2024
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Escalation
    Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose. Possibility to expand into select populations
  • Experimental: Phase 2: Dose Expansion/Optimization
    At least 2 dose levels of APL-5125 in a selected population

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events [Safety] [ Time Frame: Through study completion, approximately one year ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Florida Cancer Specialists & Research InstituteSarasotaFlorida34232
Carly Taylor
[email protected]
University of MichiganAnn ArborMichigan48109
University of Michigan Cancer AnswerLine
[email protected]
800-865-1125
Duke Cancer InstituteDurhamNorth Carolina27710
Sabina Wlazlo Cascalheiro
[email protected]
919-613-4812
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078
Hannah Wall
[email protected]
980-441-1148
704-947-6599
Medical University of South CarolinaCharlestonSouth Carolina29425-
Mary Crowley Cancer ResearchDallasTexas75251
Department Contact
[email protected]
NEXT Oncology- San AntonioSan AntonioTexas78229
Jordan Georg
[email protected]
210-580-9521

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By research site
City of Hope· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAFlorida Cancer Specialists & Research Institute· Sarasota, FLUniversity of Michigan· Ann Arbor, MIDuke Cancer Institute· Durham, NCCarolina BioOncology Institute· Huntersville, NC

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