New antibody injection enters early human trials for lung cancer
NCT ID NCT06612840
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.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2026
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: 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. 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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Shanghai East Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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