New Dual-Action antibody enters first human trials for Hard-to-Treat cancers
NCT ID NCT07660432
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 472 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITINGJinan, Shandong, 250117, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, 350014, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410013, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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The First Affiliated Hospital, Zhejiang University school of Medicine
RECRUITINGHangzhou, Zhejiang, 310003, China
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The First Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110000, China
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