Colorectal CancerPhase 1NCT06399757
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
A Phase 1 study testing APL-5125 in people with Colorectal Cancer and Cholangiocarcinoma, run by Apollo Therapeutics Ltd at 9 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cholangiocarcinoma, Appendiceal Adenocarcinoma
- What is being tested?
- APL-5125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 Jun 2024to 8 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Medical University of South Carolina
Charleston, South Carolina, 29425
Mary Crowley Cancer Research
Dallas, Texas, 75251
City of Hope
Duarte, California, 91010
Duke Cancer Institute
Durham, North Carolina, 27710
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
NEXT Oncology- San Antonio
San Antonio, Texas, 78229
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
About this study
Official title: A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
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).
Read the detailed description
The protocol was structured as a Phase 1/2 study with prespecified progression criteria informed by emerging data. Following completion of treatment for the last patient enrolled in Phase 1, it was determined that advancement to the Phase 2 portion of the protocol will not occur.
- Conditions
- Colorectal Cancer, Cholangiocarcinoma, Appendiceal Adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma
- Being tested
- APL-5125
- Medical subject headings
- Colorectal Neoplasms, Cholangiocarcinoma, Adenocarcinoma, Mucinous, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-5125Drug
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: APL-5125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: Approximately one year
Secondary outcomes (4)
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)
Response is assessed per RECIST version 1.1 criteria
Measured: 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)
Evaluate PK parameters: oral clearance
Measured: 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)
Evaluate PK parameters: volume of distribution
Measured: 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
Assessment of biomarker(s) in pre- and post-treatment tumor tissue
Measured: Through study completion, approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start18 Jun 2024
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Aggarwal, MD, Study chair, Apollo Therapeutics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399757
- Sponsor's protocol ID
- AP10CP01
- Status last verified
- Sep 2026
- First submitted
- 1 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06399757
- Acronym / sponsor ID
- AP10CP01
- Conditions
- Colorectal Cancer, Cholangiocarcinoma, Appendiceal Adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The protocol was structured as a Phase 1/2 study with prespecified progression criteria informed by emerging data. Following completion of treatment for the last patient enrolled in Phase 1, it was determined that advancement to the Phase 2 portion of the protocol will not occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Escalation | Experimental | Drug: APL-5125Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose. Possibility to expand into select populations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years or older
- Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- 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:
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Body Weight ≥40 kg.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL-5125APL-5125 is an oral drug (capsule) taken daily in 28-day cycles | Drug | Phase 1: Dose Escalation |
Primary outcome
Incidence of Treatment Emergent Adverse Events [Safety]
Time frame: Through study completion, approximately one year
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.
Incidence of dose limiting toxicities [Tolerability] (Phase 1)
Time frame: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results
Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)
Time frame: Approximately one year
4 secondary outcomes
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Through study completion, approximately one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Aggarwal, MD study chair
Apollo Therapeutics Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APL-5125 in people with Colorectal Cancer and Cholangiocarcinoma, run by Apollo Therapeutics Ltd at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events [Safety] (time frame: Through study completion, approximately one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.