Advanced MelanomaPhase 1NCT04871334
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
A Phase 1 study testing TWP-101 in people with Advanced Melanoma and Advanced Urothelial Carcinoma, run by Shandong TheraWisdom Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Melanoma, Advanced Urothelial Carcinoma
- What is being tested?
- TWP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2021to 31 Dec 2022
- Phase
- Phase 1
- 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
- Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
- ECOG score 0 or 1;
- Part B: At least 1 measurable lesion according to RECIST 1.1
Who cannot join
- Known hypersensitivity to any ingredient of TWP-101;
- Receiving any anti-cancer drugs;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, 010-88121122, guoj307@126.com
About this study
Official title: A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.
- Conditions
- Advanced Melanoma, Advanced Urothelial Carcinoma
- Being tested
- TWP-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWP-101Drug
Also called Sytalizumab Injection
IV infusion Q2W for 4 weeks (28-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Receives: Drug: TWP-101 |
| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. Receives: Drug: TWP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Measured: From the first dose of study drug up to 4 weeks
Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
Measured: From enrollment until 90 days after the last dose
Secondary outcomes (8)
Objective Response Rate (ORR) by RECIST Version 1.1
Measured: From first dose to disease progression or end of study, an average of 2 years
Duration of Response (DOR)
Measured: From first dose to disease progression, an average of 2 years
Disease control rate (DCR).
Measured: From first dose to disease progression or end of study, an average of 2 years
Progression free survival (PFS).
Measured: From first dose to disease progression or end of study, an average of 2 years
Maximum measured plasma concentration (Cmax) of TWP-101.
Measured: From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-101.
Measured: From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-101.
Measured: From first dose until 90 days after the last dose
Immunogenicity profile of TWP-101.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies by meso scale discovery(MSD).
Measured: From first dose until 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start7 Feb 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871334
- Sponsor's protocol ID
- TWP-101-11
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04871334
- Acronym / sponsor ID
- TWP-101-11
- Conditions
- Advanced Melanoma, Advanced Urothelial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 May 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.
This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: TWP-101Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. |
| Dose Expansion Cohort | Experimental | Drug: TWP-101Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
- ECOG score 0 or 1;
- Part B: At least 1 measurable lesion according to RECIST 1.1
Key exclusion criteria (5 listed)
- Known hypersensitivity to any ingredient of TWP-101;
- Receiving any anti-cancer drugs;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
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 |
|---|---|---|
| TWP-101Also: Sytalizumab InjectionIV infusion Q2W for 4 weeks (28-day cycles) | Drug | Dose Escalation Cohort, Dose Expansion Cohort |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: From the first dose of study drug up to 4 weeks
Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
Time frame: From enrollment until 90 days after the last dose
8 secondary outcomes
Objective Response Rate (ORR) by RECIST Version 1.1
Time frame: From first dose to disease progression or end of study, an average of 2 years
Duration of Response (DOR)
Time frame: From first dose to disease progression, an average of 2 years
Disease control rate (DCR).
Time frame: From first dose to disease progression or end of study, an average of 2 years
Progression free survival (PFS).
Time frame: From first dose to disease progression or end of study, an average of 2 years
Maximum measured plasma concentration (Cmax) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Immunogenicity profile of TWP-101.
Time frame: From first dose until 90 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TWP-101 in people with Advanced Melanoma and Advanced Urothelial Carcinoma, run by Shandong TheraWisdom Biopharma Co., Ltd. at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengbin Ren (8021-60167707, shengbin.ren@therawisdom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: From the first dose of study drug up to 4 weeks). 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 23 Jul 2021.