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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06399757
Other study ID # AP10CP01
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2024
Est. completion date May 2027

Study information

Verified date May 2024
Source Apollo Therapeutics Ltd
Contact Apollo Therapeutics
Phone 781-479-2267
Email AP10@apollotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 screening, 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: 1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN) (>5 x ULN for subjects with liver metastases) 2. Total bilirubin >1.5 × ULN (except participants with Gilbert's syndrome). 3. 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Apollo Therapeutics Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1) 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
Primary 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)
Primary Estimate the maximum tolerated dose (MTD) of APL-5125 in participants with selected advanced solid tumors (Phase 1) Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
Primary Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1) Approximately one year
Primary 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 Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1) 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 Assess the pharmacokinetics (PK) of APL-5125 (Phase 1) Evaluate PK parameters: oral clearance 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).
Secondary Assess the pharmacokinetics (PK) of APL-5125 (Phase 1) Evaluate PK parameters: volume of distribution 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).
Secondary Further assess the anti-tumor activity of APL-5125 (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 Incidence of treatment emergent adverse events [Further Safety] (Phase 2) 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 2 years)
Secondary Further assess the PK of APL-5125 (Phase 2) Evaluate PK parameters: oral clearance 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).
Secondary Further assess the PK of APL-5125 (Phase 2) Evaluate PK parameters: volume of distribution 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).
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