CompletedNCT04357756Updated Sep 13, 2023

A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of YH001 and Toripalimab in Advanced Solid Tumor, sponsored by Eucure (Beijing) Biopharma Co., Ltd. Completed at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Eucure (Beijing) Biopharma Co., Ltd · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 29
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This is an open-label, dose-escalation study of YH001 administered intravenously (IV) in combination with Toripalimab. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 when administered in combination with Toripalimab to subjects with advanced solid tumors.

Read the detailed description

This trial will have a run-in phase to explore the safety and tolerability of YH001 as a single agent for 21 days as DLT observation period then followed by a combination phase to further explore the safety and tolerability of YH001 combined with Toripalimab (anti-PD-1 antibody) for each dose level during dose escalation.

The dose escalation will follow the traditional "3 + 3" dose escalation scheme. These subjects will be treated with YH001 and Toripalimab. YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G. Toripalimab will be administered by IV (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle. A single subject will be enrolled at Dose A as starting dose of YH001, and subsequent cohort will be expanded to include 3-6 subjects.

Conditions studied

Advanced Solid Tumor

Browse trials for

Neoplasms 9,365

Keywords

dose escalation
safety
tolerability
advanced solid tumors
pharmacokinetics

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eucure (Beijing) Biopharma Co., Ltd is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female, aged ≥ 18 years
Have advanced histologically or cytologically confirmed solid tumor
Have progressed on after treatment with standard therapies or intolerant of standard care
At least 1 unidimensional measurable target lesion per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Have life expectancy of at least 12 weeks based on investigator's judgement

Exclusion criteria

Exclusion Criteria:

Treated with any investigational drug within 4 weeks prior to the fist dose of study drug
Received any anticancer therapy less than 28 days prior to the first administration of study drug or within 5 half-lives of the therapy agent, whichever is shorter. Prior palliative radiotherapy to bone metastases ≤ 2 weeks prior to the first dose of YH001 is acceptable
Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded
Subjects with prior PD-1/L1 treatment intolerate to PD-1/L1 therapy should be excluded
Subjects with a history of ≥ Grade 3 immune-related adverse events (AEs) resulted from previous immunotherapy or an AE of any grade that resulted in discontinuation of prior immunotherapy
Subjects with a history of ≥ Grade 2 pneumonitis resulted from previous immunotherapy or with a SpO2 by pulse oximetry \< 92% at the screening
Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug or has need to be treated while on trial. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections of steroids are allowed
Subjects with concomitant active autoimmune disease, history of autoimmune disease requiring systemic treatment, or history of autoimmune disease within the two years prior to study entry. Exceptions are subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus or hypothyroidism which can be managed by replacement therapy
Primary central nervous system (CNS) malignancies or symptomatic CNS metastases. But subjects with asymptomatic CNS metastases might be eligible if they have no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and the first dose of YH001 and are currently not receiving corticosteroids
QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome
Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE v5.0, except alopecia, \< Grade 2 sensory neuropathy

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
YH001 combined with Toripalimab
All the patients will receive YH001 intravenously as single agent for 21 days followed by combination phase.
Drug: YH001 · Drug: Toripalimab

Interventions

DrugYH001
YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G.
DrugToripalimab
Toripalimab will be administered by intravenously (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle.

What researchers measure

Primary outcomes

Number of participants with adverse events and serious adverse events
The safety profile of YH001 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: From screening up to 1 year
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle
Time frame: During Cycle 1 (each cycle is 21 days)
Dose-limiting toxicities (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to YH001) occurring during the DLT observation period (the initial 21 days) both in run-in phase of YH001 as single agent and in combination phase of YH001 in combination with Toripalimab
Time frame: During Cycle 1 (each cycle is 21 days)

Secondary outcomes

Area under the serum concentration versus time curve within one dosing interval (AUCtau)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Steady state AUC
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Maximum serum concentration (Cmax)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Trough concentration before the next dose is administered (Ctrough)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Time to reach maximum serum concentration (Tmax)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Clearance (CL)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Volume of distribution (Vd)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Terminal half-life (T1/2)
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Dose proportionality
To determine the PK profile of YH001 alone and in combination with Toripalimab
Time frame: Up to 1 year
Incidence of anti-drug antibodies (ADAs)
To assess the immunogenicity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Incidence of neutralizing antibodies (NAbs)
To assess the immunogenicity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Objective response rate (ORR)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Duration of response (DOR)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Time to response (TTR)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Progression free survival (PFS)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Overall survival (OS)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Disease control rate (DCR)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year
Duration of disease control (DDC)
To assess the preliminary antitumor activity of YH001 in combination with Toripalimab
Time frame: Up to 1 year

Study locations

3 sites

Blacktown Hospital, Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148, Australia
St George Private Hospital
Kogarah, New South Wales 2217, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria 3199, Australia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04357756
Lead sponsor: Eucure (Beijing) Biopharma Co., Ltd
Responsible party: Sponsor
First posted: Apr 22, 2020
Start date: Apr 21, 2020
Primary completion: Oct 19, 2022
Completion: Oct 19, 2022
Last update: Sep 13, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Eucure (Beijing) Biopharma Co., Ltd

Start the discussion