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New Dual-Action antibody enters first human trials for Hard-to-Treat cancers

NCT ID NCT07660432

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called SIM0689 in adults with advanced solid tumors that have stopped responding to standard treatments. SIM0689 is a bispecific antibody designed to block two cancer-promoting pathways (PD1 and VEGF). The trial will first find a safe dose, then expand to see if it shrinks tumors in specific cancer types.

What this could mean

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

Active substance
SIM0689 (a bispecific antibody targeting PD1 and VEGF)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not be safe or effective. Side effects are unknown, and only a small number of participants will receive the optimal dose.

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 472 people

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

Started

Jul 2026

Expected to finish

Jun 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: * In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy. * In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors. * Subjects must have at least one measurable lesion according to RECIST Version1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. * Adequate organ function. * Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy. * Life expectancy ≥12 weeks. * Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 180 days after the last dose. Exclusion Criteria: * Symptomatic brain metastases. * Serious non-healing wounds, ulcers or fractures. * Toxicity from previous treatment has to restore to ≤ grade 1. * Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment. * Use of aspirin (\> 325 mg/day) within 6 months prior to the first dose. * Active hepatitis B or hepatitis C. * Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). * Known hereditary or acquired predisposition to bleeding and thrombosis. * History of gastrointestinal perforation, gastrointestinal bleeding, fistula, or any life-threatening bleeding event within 6 months prior to enrollment. * Prior permanent discontinuation of PD-(L)1 and/or VEGF monoclonal antibody because of immune/anti-angiogenesis toxicities, or history of Grade ≥3 immune/anti-angiogenesis-related AEs * Known or suspected active autoimmune disease. * Patients with proteinuria at screening (Urine protein \>2+ at screening, or 2+ urine protein accompanied by 24-h urine protein ≥1 g/24 h). * History of myocardial infarction or stroke within 6 months prior to enrollment. * Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose. * Pregnant and lactating women. * Known allergies to any excipient in the study drug.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites. 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

  • Cancer Hospital of Shandong First Medical University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250117, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410013, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • The First Affiliated Hospital, Zhejiang University school of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110000, China

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