New antibody injection enters early human trials for lung cancer

NCT ID NCT06612840

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called GNC-077, a multi-specific antibody, in 20 people with advanced non-small cell lung cancer or other solid tumors that have spread. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. Participants receive the drug by IV every three weeks.

What this could mean

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

Active substance
GNC-077 multi-specific antibody injection
What this could lead to
If successful, this could point toward a new treatment option for advanced lung cancer and other solid tumors.
What could go wrong
This is an early Phase 1 trial with only 20 participants, focused on safety and dosing. It is too soon to know if the drug will be effective or have manageable side effects.
Why investors are watching

Sichuan Baili Pharmaceutical is testing GNC-077, a multi-specific antibody injection, in a small phase 1 study with 20 patients who have advanced non-small cell lung cancer or other solid tumors. For a small company, this early readout on safety and preliminary antitumor activity is a key test of whether the drug works well enough to keep developing. A clear signal of disease control could validate the company's main pipeline asset, while a weak result would raise questions about its value.

If it works: If GNC-077 shows acceptable safety and signs of tumor shrinkage or stabilization, the company could advance the drug to later-stage trials and attract partnership interest. That outcome would support the company's core research program and give investors a concrete reason to follow its progress.

If it fails: Phase 1 trials often fail because the drug proves too toxic or shows little benefit, and this study is very small, so results may be inconclusive. A poor safety profile or lack of antitumor activity could delay or end the program, which would be a major setback for a company of this size.

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

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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 20 people

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

Started

Oct 2024

Expected to finish

Oct 2026

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. Able to understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. Gender is not limited; 3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib); 4. Locally advanced or metastatic non-small cell lung cancer and other solid tumors; 5. Must have at least one measurable lesion that meets the RECIST v1.1 definition; 6. have archived primary or recurrent tumor tissue specimens that can be submitted for central review; 7. ECOG ≤1; 8. The expected survival time as judged by the investigators was ≥3 months; 9. Bone marrow function, renal function and liver function should meet the requirements; 10. Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN; 11. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose; 12. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil; 2. Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment; 3. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection; 4. No reduction in toxicity from previous antineoplastic therapy to grade I as defined in CTCAE, version 5.0, or to the level specified in the inclusion criteria; 5. Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement; 6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis; 7. Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 8. Had a history of severe cardiovascular and cerebrovascular diseases; 9. Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening; 10. Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases; 11. Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment; 12. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg); 13. Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the trial dose; 14. Had received a live vaccine within 4 weeks before the trial dose; 15. Other circumstances that the investigator deemed inappropriate for participation in the trial.

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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

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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