Trial Title:
A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
NCT ID:
NCT05789069
Condition:
Renal Cell Carcinoma
Melanoma
Non Small Cell Lung Cancer
Gastric Cancer
Colorectal Cancer
Conditions: Official terms:
Carcinoma, Renal Cell
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HFB200603
Description:
Participants will be administered HFB200603 as described in the experimental arm.
Arm group label:
Dose Escalation - HFB200603 in combination with tislelizumab
Arm group label:
Dose Escalation - HFB200603 monotherapy
Arm group label:
Dose Expansion - HFB200603 in combination with tislelizumab
Arm group label:
Dose Expansion - HFB200603 monotherapy (optional)
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Participants will be administered tislelizumab as described in the experimental arm.
Arm group label:
Dose Escalation - HFB200603 in combination with tislelizumab
Arm group label:
Dose Expansion - HFB200603 in combination with tislelizumab
Other name:
BGB-A317
Summary:
The purpose of this study is to test the safety and tolerability of HFB200603 as a single
agent and in combination with tislelizumab in patients with advanced cancers. There are
two parts in this study. During the escalation part, groups of participants will receive
increasing doses of HFB200603 as a monotherapy or in combination with tislelizumab until
a safe and tolerable dose of HFB200603 as a single agent or combination therapy is
determined. During the expansion part, participants will take the doses of HFB200603 as a
monotherapy (optional arm) or in combination with tislelizumab that were determined from
the escalation part of the study and will be assigned to a group based on the type of
cancer the participants have.
Detailed description:
This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in
adults with advanced cancers. The study will comprise of
1. A Screening Period of up to 28 days
2. A Treatment Period during which participants will receive the study drug on the
first day of each cycle where each cycle is 21 days. Number of cycles depends on how
the disease responds to the study drug
3. A Follow-up Period which involves 2 visits
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must have one of the following cancers and previously received the following
lines of systemic therapy for the advanced/metastatic disease:
- Renal cell carcinoma: at least 2 lines of therapy
- Non-small cell lung cancer: at least 2 lines of therapy
- Melanoma:
- BRAF V600E positive: must have received at least 2 lines of therapy
- BRAF V600E negative: must have received at least 1 line of therapy
- Gastric cancer: at least 1 line of therapy
- Colorectal cancer: at least 3 lines of therapy
- Suitable site to biopsy at pre-treatment and on-treatment
- Measurable disease as determined by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion Criteria:
- Systemic anti-cancer therapy within 2 weeks prior to start of study drug or within 4
weeks for immune-oncologic therapy. For cytotoxic agents with major delayed toxicity
(e.g., mitomycin C), 6 weeks of washout are mandated.
- Therapeutic radiation therapy within the past 2 weeks
- Active autoimmune diseases or history of autoimmune disease that may relapse
- Any malignancy ≤ 5 years before first dose of study drug except for the specific
cancer under investigation in this study and any locally recurring cancer that has
been treated curatively
- Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune
suppressive medication ≤ 14 days before first dose
- Patients with toxicities (as a result of prior anticancer therapy) which have not
recovered to baseline or stabilized, except for adverse events not considered a
likely safety risk (e.g., alopecia, neuropathy, and specific laboratory
abnormalities)
- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy,
or unstable psychiatric condition
- Major surgery within 28 days of the first dose of study drug
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled
lung diseases including pulmonary fibrosis or acute lung diseases. For combination
only: non-small cell lung cancer patients, or patients with significantly impaired
pulmonary function or who require supplemental oxygen at baseline must undergo an
assessment of pulmonary function at screening
- History of allergic reactions, immune related reactions, or cytokine release
syndrome (CRS) attributed to compounds of similar chemical or biologic composition
to monoclonal antibodies or any excipient of HFB200603 or tislelizumab
- For combination only: Prior randomization in a tislelizumab study regardless of the
treatment arm, until the primary and key secondary endpoints of the study have read
out
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
New Experimental Therapeutics of Virginia - NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro Ricerche Cliniche di Verona s.r.l.
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Pamplona
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
May 9, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
HiFiBiO Therapeutics
Agency class:
Industry
Source:
HiFiBiO Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789069
