Testing HS-20124 for advanced solid tumors

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 Phase 1a/1b clinical trial evaluates HS-20124, a novel antibody-drug conjugate targeting CDH6, in patients with advanced solid tumors. The study employs a multicenter, open-label design with dose escalation and expansion cohorts to assess the maximum tolerated dose, safety, pharmacokinetics, and preliminary anti-tumor activity. Patients with specific advanced solid tumor types will be included in the expansion phase to evaluate efficacy further.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least age of 18 years at screening;
2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
3. At least one extra-cranial measurable lesion according to RECIST 1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
5. Life expectancy \>= 12 weeks
6. Men or women should be using adequate contraceptive measures throughout the study;
7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1.Treatment with any of the following:

1. Previous or current treatment with CDH6 targeted therapy
2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124
5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124

Where it's running

• Affiliated Cancer Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaohua Wu, Doctor
• Email: JJYIN555@163.com
• Phone: 021-64175590-88503

Similar studies

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

• AK138D1 for advanced solid tumors

  We will try AK138D1 given by IV in adults with advanced solid tumors that haven't responded to standard treatments to find a safe dose and see if it can shrink tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang · NCT07281326

• PRaG-1 Plus PRaG Therapy with Radiation and Immunotherapy in Older Adults with Advanced Solid Tumors

  This study tests whether giving PRaG-1 Cordycepin tablets together with radiation, immune-boosting injections, and PD-1/PD-L1 inhibitors can help people aged 65 and older with advanced solid tumors.

  Recruiting Phase 2 Second Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07267234

• Cordycepin (PRaG-1) to raise CD8+ T‑cell counts after treatment for solid tumors

  This trial will test whether PRaG-1 (cordycepin) can raise low CD8+ T‑cell counts in adults who are tumor‑free after treatment for solid cancers.

  Recruiting Phase 2 Second Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07258160

• TC-G203 treatment for GPC3-positive advanced solid tumors

  This trial will test a single-dose TC-G203 cell therapy to see if it is safe and helps adults with GPC3-positive recurrent or metastatic solid tumors who have already tried other treatments.

  Recruiting Early Phase 1 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07242417

• Urolithin A (MitoPure®) with immune checkpoint inhibitors for newly diagnosed solid tumors

  This trial tests whether taking urolithin A (MitoPure®) alongside first-line immune checkpoint inhibitor therapy changes immune responses in adults with newly diagnosed solid tumors.

  Recruiting Goethe University · Frankfurt · NCT07161310

• How the CES1 liver enzyme affects capecitabine levels in people with colorectal, gastric, or esophageal cancer

  This project will see if differences in the CES1 enzyme change how capecitabine is processed and whether that affects side effects like hand‑foot syndrome in adults starting capecitabine with oxaliplatin for colorectal, gastric, or esophageal cancer.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07114627

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.