Health TrialsbyHealthPanel

A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Genuine Biotech Co., Ltd.

About this trial

A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand and voluntarily sign the informed consent form (ICF).

Aged ≥ 18 years and ≤ 75 years, regardless of gender.

Presence of at least one measurable lesion (RECIST v1.1 criteria).

ECOG performance status score of 0 or 1.

Disqualifiers

Subjects with a history of allergic reactions to GEN-725 tablets or to active or inactive excipients of drugs with similar chemical structures or of the same class.

Subjects who have received anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug, or who plan to receive such vaccines during the study period.

Subjects who have received systemic therapy with corticosteroids (> 10 mg/day of dexamethasone or equivalent dose) or other immunosuppressive drugs within 4 weeks prior to the first dose of the investigational drug. However, topical applications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted, provided the dosage does not exceed the recommended dose in the prescribing information and there are no signs of systemic exposure.

Subjects with a history of acute or chronic pancreatitis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GEN-725 tablets

    Drug

    Dose-escalation part: Subjects received GEN-725 tablets at doses of 4, 6 and 8 mg. A single oral dose was administered on Cycle 1 Day 1, observation was conducted for 4 days (i.e., after oral administration of 1 GEN-725 tablet followed by a 4-day washout period), then once daily from Day 5 onward. Dosing occurred with 21 days of continuous treatment per cycle (from Day 5 to Day 25). Dose-expansion part: Subjects received GEN-725 tablets orally at a dose that depends on the outcome of dose-escalation, administered once daily for 21 consecutive days per cycle.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with Dose-Limiting Toxicity (DLT) (Dose-escalation part)

Time frame
Day 25
2

Incidence and severity of adverse events (AEs) (Dose-escalation part)

AEs are assessed based on NCI CTCAE v5.0.

Time frame
From the signing of the Informed Consent Form (ICF) by the subjects until 28±7 days after the last administration of the study drug.
3

Overall Response Rate (ORR) (Dose-expansion part)

Time frame
Up to approximately 24 months.

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of GEN-725 (Dose-escalation part and dose-expansion part)

Time frame
Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
2

Time to Maximum Plasma Concentration (Tmax) of GEN-725 (Dose-escalation part and dose-expansion part)

Time frame
Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
3

Steady-State Valley Concentration (Css,min) of GEN-725 (Dose-escalation part and dose-expansion part)

Time frame
Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.
4

Steady-State Peak Concentration (Css,max) of GEN-725 (Dose-escalation part and dose-expansion part)

Time frame
Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.

Other outcomes

Sponsors and contacts

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

Henan Genuine Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now