Testing GH56 Capsules in Patients with Advanced Solid Tumors Lacking MTAP Gene

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of GH56 capsules in patients with advanced solid tumors that have a deletion of the MTAP gene. It is a multicenter, single-arm study that consists of two phases: a dose-escalation phase (Ia) to determine the appropriate dosage and a dose-expansion phase (Ib) to further assess the treatment's effects. Participants must have previously failed standard treatments or have no available standard therapies. The study aims to gather data on the drug's pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
2. Male and female patients who are ≥12 years of age at consent .
3. Histologically or cytologically confirmed advanced and/or metastatic malignancies with progression on / intolerance to standard treatment or lack of effective standard treatment.
4. Evidence of MTAP loss or homozygous MTAP/CDKN2A deletion in tumor tissue.
5. At least one measurable lesion as per RECIST v1.1 criteria.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
7. Survival expectations ≥ 12 weeks.
8. Adequate organ function
9. Has a negative serum pregnancy test result at screening and is able to comply with contraceptive-barrier requirements.

Exclusion Criteria:

1. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.
2. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule
3. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.
4. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56.
5. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years.
6. Uncontrolled or significant cardiovascular disease
7. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV).
8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Gansu Provincial Hospital
  Lanzhou, Gansu, China Recruiting

Study contacts

• Study coordinator: Bo Ning, Master
• Email: nibo@genhousebio.com
• Phone: +86-0512-86861608

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SY-9453 for advanced solid tumors with homozygous MTAP deletion

  This trial will test whether the oral drug SY-9453 is safe and shows anti-tumor activity in adults with advanced or metastatic solid tumors that have a homozygous MTAP deletion.

  Recruiting Phase 1 Shouyao Holdings (Beijing) Co. LTD · Shanghai · NCT07469982

• Evaluating a new drug for advanced solid tumors with a specific genetic deletion

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  Recruiting at 3 sites Phase 1 Bristol-Myers Squibb · Budapest and 2 other locations · NCT06672523

• Testing AZD3470 in patients with advanced solid tumors lacking MTAP.

  This study is testing a new drug called AZD3470 to see if it can help people with advanced solid tumors that lack a specific protein and who haven't had success with other treatments.

  Recruiting at 18 sites Phase 1/2 AstraZeneca · San Francisco, California and 20 other locations · NCT06130553

• PEP08 for adults with advanced MTAP‑deleted solid tumors

  This trial will test whether PEP08, given alone or with another cancer drug, is safe and shows signs of benefit in adults with advanced or metastatic solid tumors that have MTAP deletion.

  Recruiting at 4 sites Phase 1 PharmaEngine · Wentworthville, New South Wales and 3 other locations · NCT06973863

• Testing the safety of BAY 3713372 in patients with specific solid tumors

  This study is testing a new drug called BAY 3713372 to see if it's safe for people with specific solid tumors that have a certain genetic change and who have already tried other treatments.

  Recruiting at 45 sites Phase 1/2 Bayer · Birmingham, Alabama and 62 other locations · NCT06914128

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.