Solid TumorPhase 1/2NCT05165849
A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing GFS101A and Toripalimab in people with Solid Tumor, run by Zhejiang Genfleet Therapeutics Co., Ltd..
Trial summary
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GFS101A and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to 11 May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
- Male or female aged from 18-75 years old (inclusive).
- Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- Evaluable lesions defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
Who cannot join
- With clinically significant cardiac diseases
- With clinically significant digestive disorders.
- Other severe disease.
- Pregnant or lactating women.
- Other unfavorable situations for subjects to participate in the study judged by Investigators.
About this study
Official title: A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- GFS101A, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFS101ADrug
GFS101A will be administrated intravenously Q3W.
ToripalimabDrug
Toripalimab with fixed dose of 240 mg Q3W administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| GFS101A+Toripalimab | Experimental | Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days. Receives: Drug: GFS101A; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I：Incidence of dose limiting toxicity (DLT) events
Measured: 21days
Phase II: Overall response rate (ORR) per RECIST 1.1
Measured: approximately 12 months after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study startApr 2022 (estimated)
- Primary completion11 May 2022
- Study completion11 May 2022
Why it stopped: sponsor decided to withdraw the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165849
- Sponsor's protocol ID
- GFS101AX0101
- Status last verified
- May 2022
- First submitted
- 6 Dec 2021
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05165849
- Acronym / sponsor ID
- GFS101AX0101
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor decided to withdraw the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFS101A+Toripalimab | Experimental | Drug: GFS101A, Drug: ToripalimabPatient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
- Male or female aged from 18-75 years old (inclusive).
- Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- Evaluable lesions defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
Key exclusion criteria (5 listed)
- With clinically significant cardiac diseases
- With clinically significant digestive disorders.
- Other severe disease.
- Pregnant or lactating women.
- Other unfavorable situations for subjects to participate in the study judged by Investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFS101AGFS101A will be administrated intravenously Q3W. | Drug | GFS101A+Toripalimab |
| ToripalimabToripalimab with fixed dose of 240 mg Q3W administered intravenously. | Drug | GFS101A+Toripalimab |
Primary outcome
Phase I：Incidence of dose limiting toxicity (DLT) events
Time frame: 21days
Phase II: Overall response rate (ORR) per RECIST 1.1
Time frame: approximately 12 months after first dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GFS101A and Toripalimab in people with Solid Tumor, run by Zhejiang Genfleet Therapeutics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I：Incidence of dose limiting toxicity (DLT) events (time frame: 21days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.