A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older

• Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.

• For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer

• Phase 2: Colorectal carcinoma

• No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents:

‣ fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy

⁃ an anti-VEGF therapy

⁃ if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy

• Eastern Cooperative Oncology Group (ECOG) ≤1

• Body Weight ≥40 kg.

• Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse

• Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study

• Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial

Locations
United States
California
City of Hope
RECRUITING
Duarte
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Florida
Florida Cancer Specialists & Research Institute
RECRUITING
Sarasota
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Carolina BioOncology Institute
RECRUITING
Huntersville
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Mary Crowley Cancer Research
RECRUITING
Dallas
NEXT Oncology- San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Apollo Therapeutics
AP10@apollotx.com
781-479-2267
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2027-05
Participants
Target number of participants: 100
Treatments
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
Sponsors
Leads: Apollo Therapeutics Ltd

This content was sourced from clinicaltrials.gov

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