Clinical trial NCT05332574: A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
Official title: A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: NSCLC
Other Solid Tumors
Keywords: NSCLC
Phase 1/2
GB263T
EGFR/cMET/cMET
Lead sponsor: Genor Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age.
2. Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
3. Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. ECOG PS 0-1.
5. An expected survival time is ≥3 months.
6. Adequate organ function.
7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.

Exclusion Criteria:

1. Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug.
2. Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to the first administration of the study drug.
3. Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
4. Subjects with untreated symptomatic brain metastases.
5. History of interstitial lung disease (ILD).
6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
7. Received live virus vaccination within 30 days of first dose of study treatment.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (30 [+7] days after the last dose)
measure: DLT in Phase I
timeFrame: During Cycle 1 (up to 28 days)
measure: ORR in Phase II
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcomes:
measure: Cmax
timeFrame: At predefined intervals up to 449 days
measure: Tmax
timeFrame: At predefined intervals up to 449 days
measure: AUC0-last
timeFrame: At predefined intervals up to 449 days
measure: AUC0-τ
timeFrame: At predefined intervals up to 449 days
measure: t1/2
timeFrame: At predefined intervals up to 449 days
measure: Cmin
timeFrame: At predefined intervals up to 449 days
measure: Rac_Cmax
timeFrame: At predefined intervals up to 449 days
measure: Rac_AUC0-τ
timeFrame: At predefined intervals up to 449 days
measure: ADA
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
measure: PFS
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
measure: DOR
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
measure: CBR
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
measure: OS
timeFrame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Genesis Care
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
Study officials:
References: