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Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

ConditionsProtein Kinase InhibitorsOther Protocol Specified CriteriaLung NeoplasmsBrain Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou JOYO Pharma Co., Ltd

About this trial

An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients age 18 years or older.

Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.

Measurable disease according to RECIST version 1.1

Life expectancy of at least 3 months

Disqualifiers

Current participation in another therapeutic clinical trial.

Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.

A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.

Known active infections (bacterial, viral including HIV positivity).

Trial design

Design model

Sequential

Treatments tested in this trial

  • JYP0322 50 mg qd

    Drug

    JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 100 mg qd

    Drug

    JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 200 mg qd

    Drug

    JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 100 mg bid

    Drug

    JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 150 mg bid

    Drug

    JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 200 mg bid

    Drug

    JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

  • JYP0322 150mg tid

    Drug

    JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.

Treatment groups

101 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: 50 mg qdExperimental treatment 1 intervention
Group B: 100 mg qdExperimental treatment 1 intervention
Group C: 200 mg qdExperimental treatment 1 intervention
Group D: 100 mg bidExperimental treatment 1 intervention
Group E: 150 mg bidExperimental treatment 1 intervention
Group F: 200 mg bidExperimental treatment 1 intervention
Group G: 150 mg tidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The frequency and severity of adverse events of JYP0322

Evaluate the safety and tolerability of JYP0322 treatment. This will be assessed by: Incidence, nature, and severity of adverse events (AEs) during treatment, the proportion of patients requiring dose adjustment or permanent drug discontinuation.

Time frame
From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.

Secondary outcomes

1

Objective Response Rate (ORR)

ORR is the proportion of subjects with CR or PR , based on RECIST v1.1 criteria.

Time frame
From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.
2

Disease Control Rate (DCR)

DCR is the proportion of subjects with CR or PR or SD, based on RECIST v1.1 criteria.

Time frame
From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.
3

Duration of Response (DOR)

The time from the first documented objective response to the first occurrence of tumor progression or death from any cause.

Time frame
From the date of first response until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.
4

Time to Response (TTR)

The time from treatment initiation to the first documented objective response.

Time frame
From the first dose of study drug to the date of first objective response, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

Other outcomes

Sponsors and contacts

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

Guangzhou JOYO Pharma Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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