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A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

Primary Purpose

Gastric Cancer, Renal Cell Carcinoma, Melanoma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

HFB200301

Tislelizumab

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previously received the following lines of systemic therapy for the advanced/metastatic disease:
- Gastric cancer: at least 2 lines of therapy
- Renal cell carcinoma: at least 2 lines of therapy
- Melanoma:
  - BRAF V600E mutant: must have received at least 2 lines of therapy
  - BRAF V600E wild type: must have received at least 1 line of therapy
- Sarcoma: at least 1 line of therapy
- Testicular germ cell tumor: at least 2 lines of therapy
- Cervical cancer: at least 2 lines of therapy
- Mesothelioma: at least 2 lines of therapy
- Non-small cell lung cancer: at least 2 lines of therapy
- Head and neck squamous cell carcinoma: at least 2 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 or modified RECIST (mRECIST) for mesothelioma
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 soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
Therapeutic radiation therapy within the past 2 weeks
Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor
Active autoimmune disease requiring systemic treatment in the previous 2 years
Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune suppressive therapy ≤ 14 days before first dose
Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:
- All grades of alopecia are acceptable
- Endocrine dysfunction on replacement therapy is acceptable
Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
Major surgery within 4 weeks of the first dose of study drug
History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma 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 HFB200301
Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Dose Escalation - HFB200301 monotherapy

Dose Escalation - HFB200301 in combination with tislelizumab

Dose Expansion - HFB200301 monotherapy

Dose Expansion - HFB200301 in combination with tislelizumab

Arm Description

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Participants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs, electrocardiogram (ECG), and tolerability (dose interruptions, reductions, and dose intensity)

To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Secondary Outcome Measures

Objective Response Rate (ORR) as determined by (modified) Response Evaluation Criteria in Solid Tumors [(m)RECIST] 1.1 and immune-RECIST (iRECIST)

Disease Control Rate (DCR) as determined by (m)RECIST 1.1 and iRECIST

Duration of Response (DOR) as determined by (m)RECIST 1.1 and iRECIST

Progression Free Survival (PFS) as determined by (m)RECIST 1.1 and iRECIST

Minimum serum concentration (Cmin)

Maximum serum concentration (Cmax)

Area under the concentration versus time curve (AUC)

Terminal half-life (T1/2)

Serum concentration for measurement of anti-HFB200301 antibodies

To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination in the blood and in the tumor

Percent change in immunologic changes to immune cells in the blood and tumor

Full Information

NCT ID

NCT05238883

First Posted

December 16, 2021

Last Updated

May 18, 2023

Sponsor

HiFiBiO Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05238883

Brief Title

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

Official Title

A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HiFiBiO Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to test the safety and tolerability of HFB200301 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 HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was 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 A Screening Period of up to 28 days A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug A Follow-up Period which involves 1 visit for single agent and 2 visits for combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Testicular Germ Cell Tumor, Cervical Cancer, Mesothelioma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation - HFB200301 monotherapy

Arm Type

Experimental

Arm Description

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Arm Title

Dose Escalation - HFB200301 in combination with tislelizumab

Arm Type

Experimental

Arm Description

Arm Title

Dose Expansion - HFB200301 monotherapy

Arm Type

Experimental

Arm Description

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Arm Title

Dose Expansion - HFB200301 in combination with tislelizumab

Arm Type

Experimental

Arm Description

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

HFB200301

Intervention Description

Participants will be administered HFB200301 as described in the experimental arm.

Intervention Type

Drug

Intervention Name(s)

Tislelizumab

Other Intervention Name(s)

BGB-A317

Intervention Description

Participants will be administered tislelizumab as described in the experimental arm.

Primary Outcome Measure Information:

Title

Time Frame

Cycle 1 Day 1 to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years

Title

To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Time Frame

Cycle 1 Day 1 to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) as determined by (modified) Response Evaluation Criteria in Solid Tumors [(m)RECIST] 1.1 and immune-RECIST (iRECIST)

Time Frame

Baseline to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years

Title

Disease Control Rate (DCR) as determined by (m)RECIST 1.1 and iRECIST

Time Frame

Baseline to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years

Title

Duration of Response (DOR) as determined by (m)RECIST 1.1 and iRECIST

Time Frame

Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years

Title

Progression Free Survival (PFS) as determined by (m)RECIST 1.1 and iRECIST

Time Frame

Baseline to disease progression or death, whichever occurs first, assessed up to 3 years

Title

Minimum serum concentration (Cmin)

Time Frame

Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year

Title

Maximum serum concentration (Cmax)

Time Frame

Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year

Title

Area under the concentration versus time curve (AUC)

Time Frame

Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year

Title

Terminal half-life (T1/2)

Time Frame

Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year

Title

Serum concentration for measurement of anti-HFB200301 antibodies

Time Frame

Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year

Title

To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination in the blood and in the tumor

Description

Percent change in immunologic changes to immune cells in the blood and tumor

Time Frame

Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)

Other Pre-specified Outcome Measures:

Title

AUC vs percent of Tcell changes in the blood

Time Frame