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

NCT06399757 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AP10CP01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Endometrial Adenocarcinoma; Triple Negative Breast Cancer; Ovarian Cancer; Prostate Cancer; Colorectal Cancer; Cholangiocarcinoma; Appendiceal Adenocarcinoma; Pancreatic Adenocarcinoma; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment Emergent Adverse Events [Safety]

  Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.

  Through study completion, approximately one year

• Incidence of dose limiting toxicities [Tolerability] (Phase 1)

  Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results

  Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)

• Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)

  Approximately one year

• Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)

  Response is assessed per RECIST version 1.1 criteria

  Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)

Secondary Outcomes (8)

• Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)

  Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)

• Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)

  On days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).

• Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)

  On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).

• Evaluate biomarker(s) in the tumor

  Through study completion, approximately one year

• Further assess the anti-tumor activity of APL-5125 (Phase 2)

  Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)

Study Arms (2)

Phase 1: Dose Escalation

EXPERIMENTAL

Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose. Possibility to expand into select populations

Drug: APL-5125

Phase 2: Dose Expansion/Optimization

EXPERIMENTAL

At least 2 dose levels of APL-5125 in a selected population

Drug: APL-5125

Interventions

APL-5125 DRUG

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

Phase 1: Dose Escalation; Phase 2: Dose Expansion/Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening
• Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days
• Major surgery within 1 month of screening
• Hemoglobin \< 9.0 g/dL
• Absolute neutrophil count \< 1.5 x 10\^9/L
• Platelet count \< 100 x 10\^9/L
• Hepatic function:
• Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases)
• Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
• Albumin \< 3 g/dL
• Calculated or measured creatinine clearance of \<60 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\] / \[72 × serum creatinine mg/dL\]). Multiply result by 0.85 if female.
• Fridericia's corrected QT interval (QTcF) \>470 msec or a family history of Long QT Syndrome.
• Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) \<45% at rest
• Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C

Sponsors & Collaborators

• Apollo Therapeutics Ltd: lead

Study Sites (9)

City of Hope

Duarte, California, 91010, United States

ACTIVE NOT RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

ACTIVE NOT RECRUITING

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

RECRUITING

NEXT Oncology- San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Cholangiocarcinoma; Adenocarcinoma, Mucinous; Triple Negative Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sanjay Aggarwal, MD

  Apollo Therapeutics Ltd

  STUDY CHAIR

Central Study Contacts

Apollo Therapeutics

CONTACT

781-479-2267; AP10@apollotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)