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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04434482




Registration number
NCT04434482
Ethics application status
Date submitted
14/06/2020
Date registered
17/06/2020
Date last updated
17/09/2020

Titles & IDs
Public title
IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Scientific title
A Phase I, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Secondary ID [1] 0 0
IMP4297-106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumours 0 0
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMP4297

Experimental: IMP4297 and temozolomide - IMP4297 and temozolomide
The dose levels will be escalated following a modified 3+3 dose escalation scheme.


Treatment: Drugs: IMP4297
The dose levels will be escalated following a modified 3+3 dose escalation scheme.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety endpoints - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
MTD - the maximum tolerated dose
Timepoint [2] 0 0
Within 28 days after IMP4297 and temozolomide administrated
Primary outcome [3] 0 0
RP2D - the recommended phase 2 dose
Timepoint [3] 0 0
Within 28 days after IMP4297 and temozolomide administrated
Secondary outcome [1] 0 0
plasma PK profile - To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
anti-tumor activity - To evaluate the preliminary anti-tumor activity of IMP4297 in combination with temozolomide
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
1. The patient must voluntarily participate in this clinical study and be willing and
able to provide written informed consent/assent for the trial.

2. 18 to 75 years of age (18 and 75 included) on the day of signing informed consent form
(ICF), males or females.

3. Patient population:

1. In Part I: The patient must have histologically or cytologically confirmed
advanced solid tumor that is refractory to standard treatment or for which no
standard treatment exists.

2. In Part II: The patients must be histologically or cytologically confirmed
ES-SCLC with disease progression after the 1L standard platinum-based therapy.

3. Patients have an ECOG performance status of 0 to 1.

4. Patients have a life expectancy of =12 weeks.

5. In Part II: patients have at least 1 measurable lesion per RECIST v1.1.

4. Patients have adequate organ function, as indicated by the following laboratory values
(had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte
colony-stimulating factor, and other relevant medical support within 28 days before
the administration of the IPs).

5. Female patients should meet at least 1 of the following criteria before they can
participate in the study:

- Females who have no childbearing potential (i.e., physiologically incapable of
pregnancy), including those who have undergone hysterectomy, bilateral
oophorectomy, or bilateral salpingectomy.

- Post-menopausal (total cessation of menses for =1 year).

- For those with childbearing potential, they should have a negative serum
pregnancy test during the screening period (within 7 days prior to the first dose
of the IPs), should not be in lactation, and willing to take effective
contraceptive measures throughout the study period, from study entry up to 6
months after the last dose of the IP(s).

6. Male patients are eligible to participate in the study if they have undergone
vasectomy or agree to use effective methods of contraception from study entry up to 6
months after the last dose of the IP(s).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with primary tumor in central nervous system (CNS) and active or untreated
central CNS metastases and/or carcinomatous meningitis should be excluded. Patients
with previously treated brain metastases may participate provided they are clinically
stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases
and no requirements for corticosteroids 14 days prior to dosing with IPs.

2. Patients with serious acute and chronic infections.

3. Patients who have previously received PARP inhibitors.

4. Patients who have received a live-virus vaccination within 28 days of the planned
start of study.

5. Patients who have participated a study of an investigational agent and received study
therapy or used an investigational device within 28 days of the first dose of
treatment.

6. Patients have not recovered (i.e., to =Grade 1 or to baseline, as evaluated by
NCI-CTCAE v5.0) from cytotoxic therapy-induced AEs, except for alopecia.

7. Patients who have received chemotherapy, targeted therapy, endocrine therapy
anti-tumor Chinese herbal medicine or proprietary Chinese medicine treatment, or other
anti-cancer systemic treatment within 5 half-lives or 14 days, whichever is longer
prior to the first dose of the IPs.

8. Patients who have undergone a major surgery within 28 days prior to the study
treatment, or have undergone a radical radiotherapy, or have undergone a palliative
radiotherapy within 14 days prior to the study treatment, or have used a radioactive
drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.

9. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring
recurrent drainage procedures (once monthly or more frequently).

10. Patients with a history of seizures.

11. Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS).

12. Patients who have major cardiovascular diseases (such as congestive heart failure,
unstable angina, atrial fibrillation, arrhythmia); patients who have acute myocardial
infarction, unstable angina, stroke, or transient ischemic attack within 6 months
prior to the first dose of the IPs; patients who have congestive heart failure (=New
York Heart Association [NYHA] Classification Class II); patients who have severe
arrhythmia requiring medication (including QT interval [QTc] prolongation corrected by
the Fridericia's formula [QTcF] of more than 480 msec, pacemaker installation, and
previous diagnosis of congenital long QT syndrome).

13. Patients who are unable to swallow capsules. Patients have gastrointestinal illnesses
that may affect the absorption of oral medication IMP4297 and temozolomide.

14. Patients with a known hypersensitivity to IMP4297, temozolomide or any of the
excipients of the products.

15. Patients who have received transplantation including patients with previous allogeneic
bone marrow transplant.

16. Patients known to have a history of alcoholism or drug abuse.

17. The investigator believes that the patient's underlying disease may put the patient at
risk in IP administration or may affect the evaluation of toxicity events or AEs.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Border Medical Centre - Albury
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Orange Hospital - Orange
Recruitment hospital [4] 0 0
Peninsula Health - Frankston
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2800 - Orange
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Cheongju-si
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Gyeonggi-do
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taichung
Country [5] 0 0
Taiwan
State/province [5] 0 0
Tainan
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taipei
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Impact Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to
evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP
inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors
and with ES-SCLC who develops disease progression after 1L platinum-based regimen.
Trial website
https://clinicaltrials.gov/show/NCT04434482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bitao Z Sarapa
Address 0 0
Country 0 0
Phone 0 0
+1 (908) 303-2808
Fax 0 0
Email 0 0
bitao.sarapa@impacttherapeutics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04434482