Non-Small Cell Lung Cancer, Small Cell Lung Cancer
Conditions
Brief summary
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
Interventions
DRUGSYS6090 + pemetrexed + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.
DRUGSYS6090 + paclitaxel + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.
DRUGSYS6090 + docetaxel
In this group, participants will receive SYS6090 in combination with docetaxel.
DRUGSYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy
DRUGSYS6090 + SYS6010
In this group, participants will receive SYS6090 and SYS6010.
DRUGSYS6090 + etoposide + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.
DRUGSYS6090 + chemotherapy or other anticancer therapy
In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.
Sponsors
Shanghai JMT-Bio Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed written informed consent. 2. Age 18 to 75 years at the time of informed consent, with no restriction on sex. 3. Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy. 4. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Estimated life expectancy of at least 3 months. 7. Has protocol-defined adequate organ and bone marrow function.
Exclusion criteria
1. Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use. 2. Unresolved \> Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk). 3. For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment. 4. Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy. 5. History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment; current ILD or non-infectious pneumonitis; or inability to exclude these conditions at screening. 6. History of severe cardiovascular or cerebrovascular disease. 7. Active or recurrent autoimmune disease requiring systemic treatment, except for clinically stable or well-controlled conditions as specified in the protocol. 8. Prior immunotherapy associated with severe immune-related adverse events (≥ Grade 3) or immune-related myocarditis (≥ Grade 2), excluding stable immune-related endocrine disorders. 9. Clinically significant bleeding events (≥ Grade 2 according to NCI-CTCAE v6.0) within 4 weeks prior to the first dose of study treatment. 10. Arterial or venous thromboembolic events within 6 months prior to the first dose of study treatment, unless judged by the investigator to be clinically stable and low risk. 11. Presence of ascites or pleural effusion requiring drainage within 14 days prior to the first dose. 12. Known hypersensitivity to any component of the study treatment, history of severe hypersensitivity or infusion-related reactions to protein-based therapies, or poorly controlled asthma. 13. Untreated spinal cord compression. 14. History of other malignancies within 2 years prior to enrollment or concurrent active malignancy, except for cured localized tumors. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) (Phase II) | Through out the study (up to 2 years) | ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response. |
| Dose-Limiting Toxicity (DLT) (Phase Ib) | Approximately 21 days. | To evaluate the safety of SYS6090 in participants. |
| Adverse Events (AEs) (Phase Ib) | Up to 90 days after the last administration | To evaluate the safety of SYS6090 combination therapy in participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS) | Through out the study (up to 2 years) | Evaluation of other efficacy endpoints of SYS6090 combination therapy in participants with advanced lung cancer, assessed by the investigator according to RECIST v1.1, including duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). |
| Adverse Events (AEs) (Phase II) | Through out the study (up to 2 years) | To evaluate the safety of SYS6090 combination therapy in participants |
| Clearance (CL) of SYS6090 (and SYS6010 if applicable) | Through out the study (up to 2 years) | To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable) |
| Correlation between Biomarker Levels and Preliminary Efficacy | Through out the study (up to 2 years) | The Correlation between Baseline PD-L1 Expression and Antitumor Activity |
| Cmax of SYS6090 (and SYS6010 if applicable) | Through out the study (up to 2 years) | To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable). |
| AUC0-t of SYS6090 (and SYS6010 if applicable) | Through out the study (up to 2 years) | To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable） |
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed