Phase 2 Stomach Cancer Trial, Recruiting NCT06399757 Sponsor: Apollo Therapeutics Ltd Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT06399757
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years old or older
  • For the main Phase 1 part of the trial, you must have been diagnosed with one of these cancers that has spread or cannot be removed by surgery: colorectal cancer, bile duct cancer (cholangiocarcinoma), or appendix cancer (appendiceal adenocarcinoma)
  • For certain sub-sections of Phase 1, additional cancer types may be eligible, including: pancreatic cancer, stomach cancer, uterine cancer, triple negative breast cancer, ovarian cancer, or prostate cancer
  • For Phase 2 of the trial, you must have colorectal cancer specifically
  • You must either have no standard treatment options left available, or be unable to receive standard treatment — except for colorectal cancer patients, who must have already received specific prior treatments including: fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy; an anti-VEGF therapy; and, if your cancer has a specific genetic profile (wild-type RAS), an anti-EGFR therapy
  • You must be generally well enough to carry out light activity and care for yourself (confirm with trial site)
  • You must weigh at least 40 kg (about 88 lbs)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start, agree not to become pregnant or breastfeed during the trial, and use specific contraception methods
  • If you are a man, you must agree to use specific contraception and not donate sperm during the trial
  • You must be willing and able to give written consent and follow the trial's requirements

Who may not be able to join:

  • You have certain serious medical conditions, such as: active cancer spread to the brain, serious heart problems (including recent heart attack or unstable chest pain), uncontrolled active infection, significant bleeding in the last 4 weeks, serious bowel or stomach conditions, or a blood clot in an artery within the last 6 months
  • You have received anti-cancer treatment within the last 2 weeks, radiation therapy within the last 14 days, or are currently on blood-thinning medication
  • You have taken certain other medications, supplements, or herbal remedies within the last 14 days (confirm with trial site for specifics)
  • You have had major surgery within the last month
  • Your blood counts are too low — including red blood cells, infection-fighting white blood cells, or platelets — based on specific blood test results (confirm with trial site)
  • Your liver is not functioning well enough, based on specific blood test results (confirm with trial site)
  • Your kidneys are not functioning well enough, based on a specific calculation using your age, weight, and blood test results (confirm with trial site)
  • You have a certain type of irregular heart rhythm shown on a heart tracing test, or a family history of a condition called Long QT Syndrome
  • Your heart is not pumping strongly enough, based on a heart scan result (confirm with trial site)
  • You have HIV that is not controlled with treatment, or you have active hepatitis B or hepatitis C

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sanjay Aggarwal, MD, Apollo Therapeutics Ltd

Phone: 781-479-2267

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Apollo Therapeutics Ltd
Registry
ClinicalTrials.gov
Start date
18 June 2024
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment Emergent Adverse Events [Safety]; Incidence of dose limiting toxicities [Tolerability] (Phase 1); Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1); Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov