SYS6090 Combination Therapy in Advanced Lung Cancer

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT07472647
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6090 + pemetrexed + platinum-based chemotherapy — DRUG
    In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.
  • SYS6090 + paclitaxel + platinum-based chemotherapy — DRUG
    In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.
  • SYS6090 + docetaxel — DRUG
    In this group, participants will receive SYS6090 in combination with docetaxel.
  • SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy — DRUG
    In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy
  • SYS6090 + SYS6010 — DRUG
    In this group, participants will receive SYS6090 and SYS6010.
  • SYS6090 + etoposide + platinum-based chemotherapy — DRUG
    In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.
  • SYS6090 + chemotherapy or other anticancer therapy — DRUG
    In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.

Study Details

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.

Key Dates

First listed
Mar 16, 2026
Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
596 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6090 + Pemetrexed + Platinum
    SYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC).
  • Experimental: SYS6090 + Paclitaxel + Platinum
    SYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC).
  • Experimental: SYS6090 + Docetaxel
    SYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC).
  • Experimental: SYS6090 + Pemetrexed + Bevacizumab + Platinum
    SYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
  • Experimental: SYS6090 + SYS6010 (nsqNSCLC)
    SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
  • Experimental: SYS6090 + SYS6010 (NSCLC)
    SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC).
  • Experimental: SYS6090 + Etoposide + Platinum
    SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC).
  • Experimental: SYS6090 + Chemo/Other Anticancer Therapy
    SYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) (Phase Ib) [ Time Frame: Approximately 21 days. ]

Central Contacts

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