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Breast CancerPhase 1NCT05039931

A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study testing GNC-035 in people with Breast Cancer and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in participants with locally advanced or metastatic solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Solid Tumor
What is being tested?
GNC-035
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
15 Sep 2021to Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

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

  • The participants could understand and sign the informed consent form, and must participate voluntarily
  • No gender limit
  • Age: ≥18 years old
  • Histologically or cytologically documented, locally advanced or metastatic solid tumour,and disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment
  • Measurable disease at baseline as assessed by the Investigator per RECIST v1.1
  • ECOG Performance Status ≤ 1
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  • Life expectancy estimated to be at least 3 months
  • Acceptable bone marrow function： Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, and hemoglobin ≥ 90 g/L.
  • Acceptable renal function:
  • Creatinine (Cr) ≤ 1.5ULN or creatinine clearance (Ccr) ≥ 50 mL/min (calculated by the study site), urine protein ≤ 2 + or ≤ 1000 mg/24h (urine).
  • Acceptable liver function:
  • AST and ALT ≤ 3.0xULN (≤ 5.0ULN for patients with tumor infiltrative changes in the liver) total bilirubin ≤ 1.5xULN (≤ 3ULN for Gilbert's syndrome)
  • Coagulation function: fibrinogen ≥ 1.5 g/L, activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5×ULN
  • Female participants with fertility or male participants whose partner(s) are fertile must take effective contraceptive measures from 7 days prior to the first administration to 12 weeks after the administration. Female participants with fertility must have a negative serum/urine pregnancy test in 7 days prior to the first dose.

Who cannot join

  • Active infection requiring intravenous antibiotics and not treated within 1 week prior to enrollment, except for prophylactic antibiotics for needle stick or biopsy
  • Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA detection ≥ 10e4), or hepatitis C virus infection (HCV antibody positive with HCV-RNA ≥ ULN)
  • Toxicity from prior anticancer therapy has not been reduced to Grade I as defined in CTCAE v5.0 (with the exception of symptoms related to myelosuppression, such as neutropenia, anemia, thrombocytopenia) or to the levels specified in the inclusion criteria. Alopecia and irreversible toxicity from prior anticancer therapy (defined as stable for ≥ 2 months) allowed in the opinion of the investigator/sponsor; irAE in patients who have received prior immunotherapy and who are no longer able to receive immunotherapy as recommended by guidelines
  • Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases, may have central nervous system involvement, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, polyangitic granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain - Barré syndrome), etc.
  • Pulmonary disease defined as ≥ Grade 3 according to NCI-CTCAEv5.0, including patients with resting dyspnea, or requiring continuous oxygen therapy, or with a history of interstitial lung disease (ILD)
  • Patients with prior organ transplant
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  • Left ventricular ejection fraction ≤ 50%, or history of significant cardiac disease within 1 year
  • History or presence of thrombotic events such as deep venous thrombosis, arterial thrombosis, and pulmonary embolism
  • Received chemotherapy, molecular targeted therapy, etc., at 14 or 5 half-lives (whichever is shorter) of the first dose. Patients who have received radiotherapy, antibody therapy (such as PD-L1) or study drug within 28 days
  • Patients who had undergone major surgery within 28 days prior to dosing in this study, or who were scheduled to undergo major surgery during this study ("major surgery"was defined by the investigator)
  • Hypertension poorly controlled on medication (systolic > 150 mmHg or diastolic > 100 mmHg)
  • Previous or concomitant central nervous system disease
  • Has receivedany other clinical trial within 4 weeks prior to GNC-035 treatment

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Sichuan, Sichuan, 610041

Other trials in China

About this study

Official title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Locally Advanced or Metastatic Solid Tumors

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in participants with locally advanced or metastatic solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.

Being tested
GNC-035
Keywords
Breast Cancer, Lung Cancer
Medical subject headings
Breast Neoplasms, Lung Neoplasms

What participants receive

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

  • GNC-035Drug

    Administration by intravenous infusion.

Study groups in NCT05039931
Study groupRoleWhat they receive
GNC-035ExperimentalPatients receive GNC-035 as a 24-hour continuous intravenous infusion (cIV, QD) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles.
Receives: Drug: GNC-035

What is being measured

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

  1. DLT

    Dose limiting toxicity

    Measured: Up to 2 weeks

  2. MTD or MAD

    Maximum tolerated dose or maximum administrated dose

    Measured: Up to 2 weeks

  3. TEAE

    Treatment-Emergent Adverse Event

    Measured: Up to 2 years

  4. The recommended dose for future clinical study

    The recommended dose for future clinical study

    Measured: Up to 2 weeks

Secondary outcomes (9)

  1. AESI

    Adverse Events of special interest

    Measured: Up to 2 years

  2. Cmax

    Maximum serum concentration of GNC-035

    Measured: Up to 2 weeks

  3. Tmax

    Time to maximum serum concentration (Tmax) of GNC-035

    Measured: Up to 2 weeks

  4. T1/2

    Half-life of GNC-035

    Measured: Up to 2 weeks

  5. Incidence and titer of ADA

    Anti-drug antibody

    Measured: Up to 2 years

  6. ORR

    Objective Response Rate

    Measured: Up to 2 years

  7. DCR

    Disease Control Rate

    Measured: Up to 2 years

  8. PFS

    Progression-free Survival

    Measured: Up to 2 years

  9. DOR

    Duration of Response

    Measured: Up to 2 years

Timeline

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

  1. First posted10 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: leading entity of the clinical trial was replaced, and no patients were enrolled.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039931
Sponsor's protocol ID
GNC-035-101（V1.1）
Status last verified
Jul 2024
First submitted
22 Aug 2021
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNC-035 in people with Breast Cancer and Solid Tumor, run by Sichuan Baili 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 14 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Jul 2024. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to 2 weeks). The study lists 4 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 NCT05039931.

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 18 Jul 2024.

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