Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer

NCT06319313 | Not Yet Recruiting Phase 2

• 1 other identifier: JMT101-013
• Study Type: interventional
• Target: 534
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.

Conditions

Squamous Cell Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Overall response rate (ORR)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 3 years

• Incidence and severity of adverse events (AE) and serious adverse events (SAE)

  Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

  Up to approximately 3 years

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of response（DOR）

  Up to approximately 2 years

• JMT101 Concentrations in Plasma

  Up to approximately 2 years

• Total and Free Docetaxel Concentrations in Plasma

  Up to approximately 2 years

Study Arms (3)

JMT101+ docetaxel

EXPERIMENTAL

Drug: JMT101; Drug: docetaxel

JMT101+HB1801

EXPERIMENTAL

Drug: JMT101; Drug: HB1801

HB1801

EXPERIMENTAL

Drug: HB1801

Interventions

JMT101 DRUG

JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks.

JMT101+ docetaxel; JMT101+HB1801

docetaxel DRUG

50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks.

JMT101+ docetaxel

HB1801 DRUG

75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks.

HB1801; JMT101+HB1801

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranged from 18 to 75 years old (inclusive), regardless of gender;
• Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
• Tumor tissue available for central laboratory testing;
• Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
• Measurable disease according to RECIST1.1;
• Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
• Life expectancy ≥3 months
• Adequate main organs and bone marrow function.
• Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.

You may not qualify if:

• Previously used anti EGFR, or docetaxel;
• Central nervous system metastasis or meningeal metastasis;
• Patients with high risk of bleeding due to tumor invasion of important arteries;
• Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
• The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;
• Diagnosed as a second primary malignant tumor (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, etc.) within 5 years prior to the first administration of the study drug;
• Have received anti-tumor treatments such as systemic chemotherapy, biological therapy, immunotherapy, radical radiotherapy chemotherapy, etc. within 28 days before the first dose of the study drug;
• Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
• Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
• Have received palliative radiotherapy, small molecule targeted therapy, immunomodulatory drugs, NMPA approved modern traditional Chinese medicine preparations and other anti-tumor treatments, within 14 days before the first dose of study drug;
• Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors within 1 week, or those who cannot suspend the use of the above drugs during the study;
• Have a history of serious cardiovascular disease;
• Have a history of serious lung disease;
• History of autoimmune diseases;
• History of immunodeficiency

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Li Zhang, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share