Trial Title:
Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies
NCT ID:
NCT05577182
Condition:
Advanced Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
LAG-3
bispecific antibody
melanoma
squamous cell carcinoma of the head and neck (SCCHN)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Part 1 will be dose escalation using a statistical hybrid design to identify the RDE(s).
Part 2 will be dose expansion portion which will administer the RDE(s) defined in Part 1
to participants in 2 tumor-specific cohorts.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INCA32459-101
Description:
solution for infusion
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion Cohort Disease Group 1
Arm group label:
Part 2: Dose Expansion Cohort Disease Group 2
Summary:
This is a multicenter, open-label, single-arm study to investigate the safety,
tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants
with selected advanced malignancies. Part 1 (dose escalation) will determine the
recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD).
Part 2 (dose expansion) will further evaluate the safety, tolerability, PK,
pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended
dose(s) for expansion in 2 tumor-specific cohorts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed advanced malignancies as follows:
1. Part 1 only: Participants with the select advanced malignancies as specified in
the protocol.
2. Part 2 only:
- Cohort 1 only: Participants with Stage III (unresectable) or Stage IV
(metastatic) melanoma that is considered nonamenable to curative
treatments or procedures.
- Cohort 2 only: Participants with histologically or cytologically confirmed
recurrent/metastatic SCCHN that is PD-L1 positive (CPS ≥ 1) which is not
amenable to local therapy with curative intent.
- Participants must have experienced disease progression after treatment with standard
therapies, or are intolerant to or ineligible for standard treatment:
1. Part 1: All available standard therapies, including anti-PD-(L)1 and
platinum-based therapy, if applicable, that are known to confer clinical
benefit. Prior anti-PD-(L)1 therapy should not have been discontinued because
of intolerance.
2. Part 2: Available standard therapies, including anti-PD-(L)1 and platinum-based
therapy, if applicable, that are known to confer clinical benefit. Prior
anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
Part 2 participants may have received up to 2 prior systemic therapies in the a
advanced/metastatic setting.
- ECOG performance status of 0 or 1
- Part 2 only: Measurable disease according to RECIST v1.1.
- Part 2 only: Willingness to undergo a fresh tumor biopsy at screening (core or
excisional).
- Part 2 only: Willingness to undergo a fresh tumor biopsy at screening and
on-treatment in selected participant.
- Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
- Prior treatment with any LAG-3- or MHC Class II-directed therapy for current
malignancy, or any prior malignancy.
- Treatment with anticancer therapies or participation in another interventional
clinical study within 28 days before the first administration of study treatment
(this includes curative radiation to the thorax or systemic anticancer therapies).
- Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy
(with exceptions specified in the protocol).
- Not recovered adequately from toxicities and/or complications from surgical
intervention before starting study treatment.
- Palliative radiation therapy administered within 1 week of first dose of study
treatment or radiation therapy in the thoracic region that is > 30 Gy within 6
months of the first dose of study treatment.
- Any known additional malignancy that is progressing or requires active treatment;
history of other malignancy within 3 years of the first dose of study treatment
(with exceptions specified in the protocol).
- Evidence of interstitial lung disease or history of interstitial lung disease, or
active, noninfectious pneumonitis.
- Active autoimmune disease requiring systemic immunosuppression with corticosteroids
(> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years
before the first dose of study treatment.
- Untreated brain or CNS metastases or brain or CNS metastases that have progressed
(eg, evidence of new or enlarging brain metastasis or new neurological symptoms
attributable to brain or CNS metastases).
- Chronic treatment with systemic steroids (> 10 mg/day of prednisone or equivalent).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Facility:
Name:
University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Cliniques Universitaires Ucl Saint-Luc
Address:
City:
Bruxelles
Zip:
01200
Country:
Belgium
Facility:
Name:
Universitair Ziekenhuis Antwerpen (Uza)
Address:
City:
Edegem
Zip:
02650
Country:
Belgium
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
09000
Country:
Belgium
Facility:
Name:
Universitair Ziekenhuis Brussel
Address:
City:
Jette
Zip:
01090
Country:
Belgium
Facility:
Name:
Chu Ucl Namur University Hospital Mont-Godinne
Address:
City:
Yvoir
Zip:
05530
Country:
Belgium
Facility:
Name:
Centro Ricerche Cliniche Di Verona (Crc)
Address:
City:
Verona
Zip:
37134
Country:
Italy
Facility:
Name:
Hospital Quironsalud Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Facility:
Name:
Ico Institut Catala D Oncologia
Address:
City:
L'hospitalet de Llobregat
Zip:
08906
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Centro Integral Oncologico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Facility:
Name:
Hospital Universitario Quironsalud Madrid
Address:
City:
Pozuelo de Alarcón
Zip:
28223
Country:
Spain
Start date:
November 14, 2022
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Incyte Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577182
