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New drug combo aims to tackle Hard-to-Treat HER2 cancers

NCT ID NCT07646626

Disease control Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This Phase 2 trial is testing two experimental drugs (SSGJ-705 and SSGJ-612) with or without chemotherapy in 150 adults with advanced HER2-positive solid tumors, including colorectal, bladder, breast, bile duct, and stomach cancers. The goal is to see if the combination can shrink tumors and control the disease longer than current options. Participants must have tumors that cannot be removed by surgery or have spread.

What this could mean

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

Active substance
SSGJ-705 (a bispecific antibody targeting PD-1 and HER2) and SSGJ-612 (an anti-HER2 antibody), with or without chemotherapy
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong
This is a mid-stage (Phase 2) trial with only 150 participants, so results may not apply to everyone. The drugs may cause side effects or fail to shrink tumors in many patients.
Why investors are watching

3SBio Inc. is watching a phase II trial run by its subsidiary, Shenyang Sunshine Pharmaceutical, that tests two experimental drugs, SSGJ-705 and SSGJ-612, with or without chemotherapy, in people with advanced HER2-expressing solid tumors. The trial enrolls 150 participants and aims to control disease, so the result will show whether the drug combination shrinks or stabilizes tumors. For a small company like 3SBio, this readout matters because a positive result could support further development of its oncology pipeline, while a negative one would set back that effort.

If it works: If the trial shows the drug combination controls tumors safely, 3SBio could advance the drugs to a larger study, which may strengthen its pipeline and attract partnership interest. A positive result would be a meaningful step for a company of this size.

If it fails: If the trial fails to show disease control or shows safety problems, 3SBio would likely abandon or delay these drugs, losing the time and money spent. Trials often fail, so this outcome is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Jul 2026

Expected to finish

Oct 2028

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 to 75 years

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: * Males and/or females over age 18 * Histologically and/or cytologically documented local advanced or metastatic Colorectal adenocarcinoma (CRC), Urothelial Cancer (UC), Breast Cancer (BC), Biliary Tract Carcinoma(BTC), Gastric/Gastroesophageal Junction Cancer （G/GEJC) , etc. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival \>3 months. * Signed informed consent form. Exclusion Criteria: * Any remaining adverse events (AEs) \> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v6. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. * Pregnant or nursing women or women/men who are ready to give birth * symptomatic central nervous system metastasis. * Allergy to other antibody drugs or any excipients in the study drugs. * Inadequate organ or bone marrow function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer breast cancer colorectal adenocarcinoma gastric cancer gastroesophageal junction adenocarcinoma urothelial carcinoma

As listed by the trial registrant

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

Locally advanced (unresectable) or metastatic solid tumors

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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