Advanced MalignanciesPhase 1NCT05024305
Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
A Phase 1 study testing TWP-102 injection in people with Advanced Malignancies, run by Shandong TheraWisdom Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- TWP-102 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2022to 30 Jun 2023
- 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 confirmed advanced malignancies that failed, or not suitable for standard treatments;
- At least 1 measurable lesion.
- ECOG score 0 or 1;
- Life expectancy of ≥ 3 months;
Who cannot join
- Known hypersensitivity to any ingredient of TWP-102;
- Receiving any anti-cancer drugs within 4 weeks;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)
- Pregnancy or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150001
Qingyuan Zhang, 0451-86298070
About this study
Official title: A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
- Conditions
- Advanced Malignancies
- Being tested
- TWP-102 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWP-102 injectionDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Four dose levels of TWP-102 injection will be tested by BOIN study design. Receives: Drug: TWP-102 injection |
| Dose Expansion Cohort | Experimental | Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors. Receives: Drug: TWP-102 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events/serious adverse event related with TWP-102 injection
Measured: From enrollment until 90 days after the last dose
Dose-limiting toxicity (DLT)
Measured: From the first dose of study drug up to 3 weeks
Secondary outcomes (8)
Maximum measured plasma concentration (Cmax) of TWP-102 injection.
Measured: From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-102 injection.
Measured: From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-102 injection.
Measured: From first dose until 90 days after the last dose
Immunogenicity profile of TWP-102 injection.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Measured: From first dose until 90 days after the last dose
Objective Response Rate (ORR)
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 or end of study, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start8 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT05024305
- Sponsor's protocol ID
- TWP-102-11
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 9 Mar 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
- ClinicalTrials.gov ID
- NCT05024305
- Acronym / sponsor ID
- TWP-102-11
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Aug 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 is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: TWP-102 injectionFour dose levels of TWP-102 injection will be tested by BOIN study design. |
| Dose Expansion Cohort | Experimental | Drug: TWP-102 injectionOnce the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;
- At least 1 measurable lesion.
- ECOG score 0 or 1;
- Life expectancy of ≥ 3 months;
Key exclusion criteria (6 listed)
- Known hypersensitivity to any ingredient of TWP-102;
- Receiving any anti-cancer drugs within 4 weeks;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)
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-102 injectionIV infusion | Drug | Dose Escalation Cohort, Dose Expansion Cohort |
Primary outcome
Incidence of adverse events/serious adverse event related with TWP-102 injection
Time frame: From enrollment until 90 days after the last dose
Dose-limiting toxicity (DLT)
Time frame: From the first dose of study drug up to 3 weeks
8 secondary outcomes
Maximum measured plasma concentration (Cmax) of TWP-102 injection.
Time frame: From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-102 injection.
Time frame: From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-102 injection.
Time frame: From first dose until 90 days after the last dose
Immunogenicity profile of TWP-102 injection.
Time frame: From first dose until 90 days after the last dose
Objective Response Rate (ORR)
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 or end of study, 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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-102 injection in people with Advanced Malignancies, 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 4 inclusion and 6 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 9 Mar 2022. 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 adverse events/serious adverse event related with TWP-102 injection (time frame: From enrollment until 90 days after the last dose). 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 9 Mar 2022.