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Advanced Solid TumorsPhase 1NCT07230977

GenSci139 in Patients With Advanced Solid Tumors

A Phase 1 study testing GenSci139 in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
GenSci139
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
19 Nov 2025to 8 Jan 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci139 and any study procedures).
  • Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.
  • Adult participants (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.
  • Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and if not available, providing other archival tumor tissue specimens or not may be enrolled after discussion with sponsor.
  • Has at least one measurable lesion by RECIST v1.1.
  • Has an eastern cancer collaboration group (ECOG) status of 0 or 1.
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  • Left ventricular ejection fraction (LVEF) ≥50%.
  • Has a life expectancy of ≥ 3 months.
  • Has adequate hematologic and organ function prior to initiation dose of GenSci139.
  • Women of childbearing potential (WOCBP) must be willing to use adequate contraception while receiving GenSci139, and within 6 months after the last dose of GenSci139 and have a negative serum human chorionic gonadotropin (HCG) test.
  • Nonsterile males must be willing to use adequate contraception for the duration of receiving GenSci139 and within 6 months after the last dose of GenSci139.
  • Has histologically or cytologically confirmed locally advanced or metastatic UC, HNSCC, TNBC, NSCLC, BTC, ESCC, GC, CRC, OC, NPC, PDAC etc. and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.

Who cannot join

  • Any active malignancy within 3 years before initiation dose of GenSci139 except for the cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), carcinoma in situ of the cervix or breast).
  • Has diagnosed as primary central nervous system (CNS) tumor.
  • Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 4 weeks prior to initiation dose of GenSci139.
  • Has a history of leptomeningeal disease or spinal cord compression.
  • Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci139.
  • Active autoimmune diseases and inflammatory diseases.
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  • Has a history of (non-infectious) interstitial lung disease (ILD) / pneumonitis that required steroids, has current ILD / pneumonitis, or where suspected ILD / pneumonitis cannot be ruled out by imaging at screening.
  • Unstable thrombotic events within 6 months prior to initiation dose of GenSci139.
  • Has severe chronic or active infection
  • Uncontrolled hypertension
  • Has clinically significant cardiovascular disease
  • Known severe hypersensitivity to GenSci139 and/or any of its excipients.
  • Has a history of severe hypersensitivity reactions to other monoclonal antibodies
  • With enough washout period to some therapies specified in protocol.
  • Known HIV infection, active HBV or HCV infection.
  • Has unresolved toxicities from previous anticancer therapy
  • Had received HER2 or EGFR monoclonal antibodies, or using TOPO I inhibitor as payload, targeted to HER2 or EGFR ADC, and could not be intolerance of those treatment.
  • Women who are pregnant or lactating or are planning to become pregnant.
  • Uncontrollable pleural effusion, pericardial effusion, or abdominal and pelvic effusion requiring drainage and/or diuretics within 14 days prior to GenSci139 infusion.
  • The other conditions of participation in this clinical trial were not considered appropriate by the investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinming Yu, MD contact

0531-67626971

sdyujinming@126.com

China1 site, 1 recruiting

  • Shandong First Medical University Affiliated Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Two-Part, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activities of GenSci139 in Patients With Locally Advanced or Metastatic Solid Tumors

This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.

Being tested
GenSci139

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenSci139Drug

    GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.

Study groups in NCT07230977
Study groupRoleWhat they receive
Part1 dose escalationExperimentaldose escalation cohorts of GenSci139 in sequential ascending order
Receives: Drug: GenSci139
Part 1 backfillExperimentalbackfill study at dose levels proved safety and efficacy during dose escalation
Receives: Drug: GenSci139
Part 2 dose expansionExperimentalDose expansion at RDE dose levels with selected advanced cancers.
Receives: Drug: GenSci139

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and Part2: Incidence of adverse events

    Percentage of patients with adverse events by system organ class and preferred term

    Measured: From time of informed consent to 30 days post last dose of GenSci139

  2. Dose limiting toxicities (DLTs)

    DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocol

    Measured: from time of first dose of GenSci139 to end of DLT observation period(approximately 21 days)

  3. Part1: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)

    To determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci139

    Measured: from time of first dose of GenSci139 up to 18 months

  4. Part2: Objective response rate(ORR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.

    Measured: approximately 12 months

  5. Part2: disease control rate (DCR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DCR using RECIST criteria v1.1.

    Measured: approximately 12 months

  6. Part2: Duration of response (DoR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DoR using RECIST criteria 1.1.

    Measured: approximately 24 months

Secondary outcomes (25)

  1. Cmax of GenSci139

    Calculate maximum observed concentration of GenSci139

    Measured: approximately 24 months

  2. Part1: Cmax of total antibody

    Calculate maximum observed concentration of total antibody

    Measured: approximately 24 months

  3. Part1: Cmax of free payload

    Calculate maximum observed concentration of free payload

    Measured: approximately 24 months

  4. Part1: Tmax of GenSci139

    Calculate time of maximum observed concentration of GenSci139

    Measured: approximately 24 months

  5. Part1: Tmax of total antibody

    Calculate time of maximum observed concentration of total antibody

    Measured: approximately 24 months

  6. Part1: Tmax of free payload

    Calculate time of maximum observed concentration of free payload

    Measured: approximately 24 months

  7. Part1: AUC of GenSci139

    Calculate area under the curve of GenSci139

    Measured: approximately 24 months

  8. Part1: AUC of total antibody

    Calculate area under the curve of total antibody

    Measured: approximately 24 months

  9. Part1: AUC of free payload

    Calculate area under the curve of free payload

    Measured: approximately 24 months

  10. Part1: Objective response rate(ORR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.

    Measured: approximately 12 months

  11. Part1: disease control rate (DCR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DCR using RECIST criteria v1.1.

    Measured: approximately 12 months

  12. Part1: Duration of response (DoR)

    To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DoR using RECIST criteria 1.1.

    Measured: approximately 24 months

  13. Part1: ADA of GenSci139

    Incidence and titer of anti-drug antibody (ADA)

    Measured: approximately 24 months

  14. Part1: NAb of GenSci139

    Incidence and titer of neutralizing antibody (NAb)

    Measured: approximately 24 months

  15. Part2: Cmax of GenSci139

    Calculate maximum observed concentration of GenSci139

    Measured: approximately 24 months

  16. Part2: Cmax of total antibody

    Calculate maximum observed concentration of total antibody

    Measured: approximately 24 months

  17. Part2: Cmax of free payload

    Calculate maximum observed concentration of free payload

    Measured: approximately 24 months

  18. Part2: Tmax of GenSci139

    Calculate time of maximum observed concentration of GenSci139

    Measured: approximately 24 months

  19. Part2: Tmax of total antibody

    Calculate time of maximum observed concentration of total antibody

    Measured: approximately 24 months

  20. Part2: Tmax of free payload

    Calculate time of maximum observed concentration of free payload

    Measured: approximately 24 months

  21. Part2: AUC of GenSci139

    Calculate area under the curve of GenSci139

    Measured: approximately 24 months

  22. Part2: AUC of total antibody

    Calculate area under the curve of total antibody

    Measured: approximately 24 months

  23. Part2: AUC of free payload

    Calculate area under the curve of free payload

    Measured: approximately 24 months

  24. Part2: ADA of GenSci139

    Incidence and titer of anti-drug antibody (ADA)

    Measured: approximately 24 months

  25. Part2: NAb of GenSci139

    Incidence and titer of neutralizing antibody (NAb)

    Measured: approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start19 Nov 2025
  3. Primary completion7 Jul 2028 (estimated)
  4. Study completion8 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230977
Sponsor's protocol ID
GenSci139-101
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GenSci139 in people with Advanced Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinming Yu, MD (0531-67626971, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part2: Incidence of adverse events (time frame: From time of informed consent to 30 days post last dose of GenSci139). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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