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New drug combo targets Hard-to-Treat cancers with specific gene deletion

NCT ID NCT07699757

Disease control Sponsor: Haisco Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests an experimental drug called HSK41959, taken as a tablet, in combination with standard cancer treatments for people with advanced solid tumors that lack a gene called MTAP. The trial includes patients with non-small cell lung cancer, pancreatic cancer, and other advanced solid tumors. The main goals are to check the safety and tolerability of the combination and to get an early look at how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK41959
What this could lead to
If successful, this could point toward a new treatment option for people with certain hard-to-treat cancers that have an MTAP gene deletion.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or could cause unexpected side effects. Results are preliminary and need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult participants aged 18 years or older. 2. ECOG performance status of 0 to 1. 3. Life expectancy of at least 3 months. 4. Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay. 5. At least one measurable lesion according to RECIST version 1.1. 6. For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements. 7. For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements. 8. Adequate bone marrow, hepatic, renal, and coagulation function. 9. Willingness to provide tumor tissue and/or undergo protocol-required biomarker testing, if applicable. Exclusion Criteria: 1. Prior exposure to agents targeting the MAT2A or PRMT5 pathway. 2. Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout/recovery requirements. 3. Known actionable driver alterations or prior therapies excluded by the protocol for specific NSCLC cohorts (for example EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS G12C, HER2, as applicable). 4. Significant gastrointestinal disorders that may affect drug absorption. 5. Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure. 6. Uncontrolled metabolic disease, uncontrolled hypertension, or active infection. 7. Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection. 8. Use of prohibited concomitant medications, including strong inhibitors or inducers of CYP3A4, P-gp, BCRP, or other protocol-specified transporters/enzymes within the required washout period. 9. Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Non small cell lung cancer Pancreatic ductal adenocarcinoma (mpdac)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, China

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