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SYS6090 Combination Therapy in Advanced Lung Cancer

ConditionsNon-Small Cell Lung CancerSmall Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai JMT-Bio Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed written informed consent.

Age 18 to 75 years at the time of informed consent, with no restriction on sex.

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.

At least one measurable lesion according to RECIST v1.1.

Disqualifiers

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.

Unresolved > Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).

For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

596 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: SYS6090 + Pemetrexed + PlatinumExperimental treatment 1 intervention
Group B: SYS6090 + Paclitaxel + PlatinumExperimental treatment 1 intervention
Group C: SYS6090 + DocetaxelExperimental treatment 1 intervention
Group D: SYS6090 + Pemetrexed + Bevacizumab + PlatinumExperimental treatment 1 intervention
Group E: SYS6090 + SYS6010 (nsqNSCLC)Experimental treatment 1 intervention
Group F: SYS6090 + SYS6010 (NSCLC)Experimental treatment 1 intervention
Group G: SYS6090 + Etoposide + PlatinumExperimental treatment 1 intervention
Group H: SYS6090 + Chemo/Other Anticancer TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT) (Phase Ib)

To evaluate the safety of SYS6090 in participants.

Time frame
Approximately 21 days.
2

Adverse Events (AEs) (Phase Ib)

To evaluate the safety of SYS6090 combination therapy in participants.

Time frame
Up to 90 days after the last administration
3

Objective response rate (ORR) (Phase II)

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.

Time frame
Through out the study (up to 2 years)

Secondary outcomes

1

Cmax of SYS6090 (and SYS6010 if applicable)

To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable).

Time frame
Through out the study (up to 2 years)
2

AUC0-t of SYS6090 (and SYS6010 if applicable)

To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable）

Time frame
Through out the study (up to 2 years)
3

Clearance (CL) of SYS6090 (and SYS6010 if applicable)

To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable)

Time frame
Through out the study (up to 2 years)
4

Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS)

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).

Time frame
Through out the study (up to 2 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai JMT-Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: