Refractory or Recurrent CD30+ Hematologic MalignanciesPhase 1NCT03894150
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
A Phase 1 study testing F0002-ADC in people with Refractory or Recurrent CD30+ Hematologic Malignancies, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory or Recurrent CD30+ Hematologic Malignancies
- What is being tested?
- F0002-ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 11 Apr 2019to 12 Mar 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- With relapsed/refractory CD30+ disease that histologically confirmed by central laboratory assessment and pathology review (Priority for cHL, ALCL and MF).
- Patients must have at least one site of measurable disease by conventional CT scan (defined by unidimensional lymph node lesion ≥ 15 mm or extranodal lesion ≥ 10 mm ), patients with MF, skin nodules can be measured by caliper to meet the criteria as measurable lesions, positive FDG uptake for cHL and ALCL.
- Patients must have the following required baseline laboratory data: Hb≥80g/L, NEUT≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5 times ULN, ALT/AST≤2.5 times ULN, Cr≤1.25 times ULN or Ccr≥45 ml/min, INR≤1.5 times ULN, APTT≤1.5 times ULN.
- Patients must be at least 8 weeks apart from the previous autologous stem cell infusion therapy prior to the first dose.
- Patients must be at least 4 weeks apart from previous radiotherapy, chemotherapy, biologics, immunotherapy, and/or other research-based anticancer therapy prior to the first dose (with nitrogen mustard, melphalan, and nitrosourea for at least 6 weeks).
- Patients must have a life expectancy > 3 months.
- Voluntary consent form
Who cannot join
- Patients who have received an allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
- Patients received antibody therapy 6 weeks or 5 plasma half-life before the first dose.
- Patients who are receiving other anti-tumor treatments.
- The toxicity of previous anti-tumor treatment has not recovered to grade 1 or below, except for grade 2 peripheral neurotoxicity and any level of alopecia.
- Other primary malignant tumors have been seen in the past 3 years (except for cervical cancer in situ or non-melanoma skin cancer or prostate cancer with specific prostate specific antigen).
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- Participants with cardiovascular conditions specified in protocols.
- NYHA classification grading of cardiac function III/IV.
- Participants with brain or meningeal disease conditions specified in protocols.
- Patients with poor diabetes control,
- High-risk participants with a history of > grade 2 peripheral neuropathy or any active neurologic disease.
- Patients have psychiatric history.
- Patients with a history of liver fibrosis or cirrhosis and clinical signs and symptoms suggesting liver fibrosis or cirrhosis.
- Patients with previous interstitial pneumonia.
- Patients have active systemic viral, bacterial or fungal infection 4 weeks prior to the first dose
- HIV antibody positive / HBsAg positive / HCVAb positive.
- Patients who are allergic to recombinant proteins, murine proteins or to the drug excipients.
- Patients who are receiving a dose ≥ 20 mg/day of prednisone or glucocorticoid therapy.
- Female patients who are breastfeeding or pregnant.
- Patients with fertility who refuses to use contraception during the trial period and within 6 months after the end of the last dose.
- Other reasons that researchers believe are inappropriate to participate in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.
- Being tested
- F0002-ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F0002-ADCDrug
Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| F0002-ADC | Experimental | Not described Receives: Drug: F0002-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
the maximum tolerable dose
Measured: Within 21 days after a single dose
Secondary outcomes (12)
ORR
Objective response rate
Measured: Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years
DOR
Duration of Response
Measured: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
PFS
Progress Free Survival
Measured: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
Maximum Plasma Concentration [Cmax]
pharmacokinetic parameter
Measured: 1 months after last dose
Area Under the Curve [AUC]
pharmacokinetic parameter
Measured: 1 months after last dose
Tmax
pharmacokinetic parameter
Measured: 1 months after last dose
Half-life Time [T1/2]
pharmacokinetic parameter
Measured: 1 months after last dose
Clearance [CL]
pharmacokinetic parameter
Measured: 1 months after last dose
Apparent Volume of Distribution [Vd]
pharmacokinetic parameter
Measured: 1 months after last dose
Immunogenicity
Anti-F0002-ADC Antibodies
Measured: 1 months after last dose
Incidence of adverse events
Measured: Till 1 month after last dose
Incidence of laboratory abnormalities
Measured: Till 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start11 Apr 2019
- Primary completion1 Jul 2020
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory or Recurrent CD30+ Hematologic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894150
- Sponsor's protocol ID
- F0002-01
- Status last verified
- May 2024
- First submitted
- 26 Mar 2019
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
- ClinicalTrials.gov ID
- NCT03894150
- Acronym / sponsor ID
- F0002-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 28 Mar 2019 (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 Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F0002-ADC | Experimental | Drug: F0002-ADC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- With relapsed/refractory CD30+ disease that histologically confirmed by central laboratory assessment and pathology review (Priority for cHL, ALCL and MF).
- Patients must have at least one site of measurable disease by conventional CT scan (defined by unidimensional lymph node lesion ≥ 15 mm or extranodal lesion ≥ 10 mm ), patients with MF, skin nodules can be measured by caliper to meet the criteria as measurable lesions, positive FDG uptake for cHL and ALCL.
- Patients must have the following required baseline laboratory data: Hb≥80g/L, NEUT≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5 times ULN, ALT/AST≤2.5 times ULN, Cr≤1.25 times ULN or Ccr≥45 ml/min, INR≤1.5 times ULN, APTT≤1.5 times ULN.
- Patients must be at least 8 weeks apart from the previous autologous stem cell infusion therapy prior to the first dose.
Key exclusion criteria (21 listed)
- Patients who have received an allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
- Patients received antibody therapy 6 weeks or 5 plasma half-life before the first dose.
- Patients who are receiving other anti-tumor treatments.
- The toxicity of previous anti-tumor treatment has not recovered to grade 1 or below, except for grade 2 peripheral neurotoxicity and any level of 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 |
|---|---|---|
| F0002-ADCEvery 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg | Drug | F0002-ADC |
Primary outcome
MTD
Time frame: Within 21 days after a single dose
the maximum tolerable dose
12 secondary outcomes
ORR
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years
DOR
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
PFS
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
Maximum Plasma Concentration [Cmax]
Time frame: 1 months after last dose
Area Under the Curve [AUC]
Time frame: 1 months after last dose
Tmax
Time frame: 1 months after last dose
Half-life Time [T1/2]
Time frame: 1 months after last dose
Clearance [CL]
Time frame: 1 months after last dose
Apparent Volume of Distribution [Vd]
Time frame: 1 months after last dose
Immunogenicity
Time frame: 1 months after last dose
Incidence of adverse events
Time frame: Till 1 month after last dose
Incidence of laboratory abnormalities
Time frame: Till 1 month after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F0002-ADC in people with Refractory or Recurrent CD30+ Hematologic Malignancies, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 2 sites 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 8 inclusion and 21 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD (time frame: Within 21 days after a single dose). 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 14 May 2024.