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RecruitingLast updated: 27 February 2026

This trial is studying a drug called YL242 in combination with other treatments in people with advanced or metastatic solid cancersA Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This is a study that is evaluating how safe and tolerable a drug called YL242 is when given by itself and in combination with other treatments in people with advanced solid cancers.

The study has multiple parts.

Part 1 and Part 2
In this part, YL242 will be evaluated by itself (monotherapy). Participants will receive YL242 as an intravenous infusion (IV). People with advanced, unresectable or metastatic solid cancers who have received at least one prior line of systemic anti-cancer therapy.

Part 3 and 4
This part will evaluate a combination dose of YL242 in combination with pembrolizumab immunotherapy. Part 3 will enrol the same people as Parts 1 and 2, while Part 4 will enrol people with locally advanced or metastatic non-squamous non-small cell lung cancer without AGA and HCC, who have not received any systemic anti-cancer treatment.

Part 5
In this part, participants will receive YL242 in combination with chemotherapy - 5FU and LV. This part will enrol people with metastatic colorectal cancer who have received at least one (5a) or one (5b) prior line of systemic anti-tumour treatment.

Part 6
In this part, participants will receive YL242 with pembrolizumab immunotherapy and 5-FU chemotherapy. This part will enrol people with advanced or metastatic HER-negative gastric or gastro-oesophageal junction cancer who have received at least one (6a) or one (6b) prior line of systemic anti-cancer therapy.

Conditions

This trial is treating people with advanced, metastatic or unresectable solid cancers, including non-small cell lung cancer, colorectal cancer, stomach cancer or gastro-oesophageal junction cancer

Eligibility

Inclusion

  • Aged ≥18 years.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Adequate organ and bone marrow function
  • Tumor type:

Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy

Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;

Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy

Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy

Exclusion

  • Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
  • Clinically significant concomitant pulmonary disease
  • A history of leptomeningeal carcinomatosis or carcinomatous meningitis
  • Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Scientific Title

A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.

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