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Advanced Solid TumorsPhase 1WEE1NCT04768868

The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors

A Phase 1 study testing IMP7068 in people with Advanced Solid Tumors, run by Impact Therapeutics, Inc. at 16 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 1 Dose Escalation and Expansion Study of IMP7068 Monotherapy in Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
IMP7068
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
16 sitesin 3 countries
Study dates
25 Feb 2021to 30 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must voluntarily participate in this clinical study. Be willing and able to provide written informed consent form (ICF) prior to any study activity.
  • Age ≥18 years on the day of signing the ICF, males or females. Only for Korea, Age ≥19 years on the day of signing the ICF.
  • The enrolled patients must have histologically or cytologically confirmed advanced solid tumor that is refractory/intolerant to standard treatment or for which no standard treatment exists. The patients with known microsatellite-instability high (MSI-H) or deficient in mismatch repair (dMMR) disease are required to have received prior PD 1/PD-L1 therapy; those with known NTRK fusion are required to have received an approved TRK-inhibitor. The patients who are suitable for resection or other localized therapy that is potentially curative are not eligible.

Who cannot join

  • Patients with active or untreated known CNS metastases and/or carcinomatous meningitis should be excluded.
  • Patients with serious acute or chronic infections.
  • Patients who have received prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 7 days prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of IMP7068.
  • Patients who are participating in or have participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
  • Patients have not recovered (i.e., to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE Version 5.0) from prior anti-cancer therapy-induced AEs, except for alopecia, anorexia or CTCAE grade 2 peripheral neuropathy.
  • Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the study treatment, 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.
  • Patients who are unable to swallow oral medications. Patients have gastrointestinal illnesses that may clinically significantly affect the absorption of oral medication IMP7068 at discretion of investigators.

Trial locations and contacts

16 sites in 3 countries.

Jian Wang contact

+86 18613056501

Jian.wang@impacttherapeutics.com

16 sites in 3 countries

United States7 sites, 6 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Stephen Bocarro, 404-778-8670, stephen.rupert.bocarro@emory.edu

    (404) 778-8670, nina.cathleen.dobbs.kimball@emory.edu

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

    Joyce Liu, 877-338-7425, joyce_liu@dfci.harvard.edu

    Joyce Liu, MD

    Not yet recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Avery Fields, 972-566-3016, AFields@marycrowley.org

    Michael Hager, 214-658-1962, mhagar@marycrowley.org

    Recruiting

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

    Anna Tay, 913-574-1319, atay@kumc.edu

    Xuan Lam, (913) 945-7551, xlam@kumc.edu

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

    Withdrawn

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    Ben Orem, 502-629-2500 ext. 19471, Ben.Orem@nortonhealthcare.org

    Pamela Adkisson, 502-629-2500 ext. 19460, Pamela.Adkisson@nortonhealthcare.org

    Recruiting

  • Next Oncology

    San Antonio, Texas, 78229

    Nicole Klein, 737-610-5200, nklein@nextoncology.com

    Romeena Momin, (210) 253-2572, rmomin@nextoncology.com

    Recruiting

Other trials in United States

Taiwan5 sites, 5 recruiting

  • China Medical University Hospital

    Taichung, 40447

    Pei-Chen Hsu, 886-4-22052121 ext. 5051, peggyshiu0807@gmail.com

    Li-Yuan Bai, MD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Yi-Zeng Wang, 886-6-2353535 ext. 3974, yizeng95020@gmail.com

    Yu-Min Yeh, MD

    Recruiting

  • Chi Mei Hospital, Liouying

    Tainan, 73657

    Demi Lee, 886-6-6226999 ext. 73132, pixie0811@gmail.com

    Yen-Hsun Chen, MD

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Ying-Jan Chen, 886-2-23123456 ext. 68057, 107413@ntuh.gov.tw

    Chia-Chi Lin, MD

    Recruiting

  • Chang Gung Medical Foundation - Linkou Branch

    Taoyuan, TW, 333

    Yi-Ting Yang, 886-989-336747, kikikoko1110@gmail.com

    Hung-Chih Hsu, MD

    Recruiting

Other trials in Taiwan

China4 sites, 4 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Yuanyuan Zhang, 15724546682, yuanyuan.zhang@rg-pharma.com

    Lin Shen, MD

    Recruiting

  • West China 2nd University Hospital

    Chengdu, Sichuan, 610066

    Qin Zou, 028-85503776, hxeygcp@163.com

    Rutie Yin, MD

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 201321

    Xiao-Hua Wu, MD

    Recruiting

  • Wuhan Union Hospital

    Wuhan, HB, 430030

    Wanqing Ji, 027-85726685, whuniongcp@126.com

    Guiling Li, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1 Dose Escalation and Expansion Study of IMP7068 Monotherapy in Advanced Solid Tumors

Read the detailed description

This is A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors

The study will include a dose-escalation stage and a dose-expansion stage. The dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and select recommended Phase 2 dose (RP2D) of IMP7068 monotherapy. The dose-expansion stage will be conducted with RP2D to further evaluate the preliminary anti-tumor activity, safety and tolerability.

A total of approximately 140-350 patients will be enrolled in the study.

Approximately 60-100 patients will be enrolled into Part 1 dose escalation of IMP7068 monotherapy. A total of 100 patients each with advanced solid tumor will be evaluated in Part 2 dose-expansion of IMP7068 monotherapy.

Being tested
IMP7068
Keywords
Breast Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancers
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMP7068Drug

    To evaluate the safety tolerability, pharmacokinetics, and anti-tumor activity of the WEE1 inhibitor IMP7068 monotherapy in patients with advanced solid tumors

Study groups in NCT04768868
Study groupRoleWhat they receive
IMP7068OtherPart 1: Dose Escalation The study will begin with open-label dose escalation in IMP7068 monotherapy treatment to determine the Maximum tolerated dose (MTD) Part 2: Dose Expansion The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. A total of 100 patients each with advanced solid tumor who has exhausted available treatment options will be evaluated.
Receives: Drug: IMP7068

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Dose Escalation: Incidence of treatment emergent adverse events (TEAEs)

    Measured: Day 1 through to 30 days after last dose (approximately 4 cycles (84 days plus 30 day follow-up )); Each cycle is 21 days

  2. Part 1 Dose Escalation: Severity of treatment emergent adverse events (TEAEs), according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

    Measured: Day 1 through to 30 days after last dose (approximately 4 cycles (84 days plus 30 day follow-up )); Each cycle is 21 days

  3. Part 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy

    Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy (selected by the safety monitoring committee (SMC) based on pharmacokinetics, target saturation at steady state, pharmacodynamics, safety, tolerability and preliminary anti-tumor effects of the dose range studied)

    Measured: Day 1 through to start of dose expansion phase (approximately 1 year)

  4. Part 2 Dose Expansion: Overall Response Rate (ORR)

    Overall Response Rate (ORR) for all cohorts (percentage of patients who had a best response rating of complete response (CR) and partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, which was maintained ≥4 weeks)

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

Secondary outcomes (10)

  1. Plasma Concentration of IMP7068

    Measured: Day -7 to repeat dose Day 1; postdose at multiple time points from Day 1 to Day 21 in Cycle 1 (Cycle 1 = 21 days), Day 1 on Cycle 2 (Cycle 2 onwards = 21 day-cycles) and subsequent cycles (Up to 26 months)

  2. Part 1 Dose Escalation: Objective response rate (ORR): percentage of patients who had a best response

    Measured: Within the first year: every 6 weeks, thereafter every 12 weeks to end of treatment (EOT) visit (approximately 84 days), documented disease progression, withdrawal of consent, loss to follow-up, death or termination of the study (whichever occurs first)

  3. Part 1 Dose Escalation: Progression-free survival (PFS): duration of time from date of first dose to date of disease progression (according to RECIST v1.1) or death due to any cause, whichever comes first)

    Measured: Within the first year: every 6 weeks (±7 days); thereafter: every 12 weeks (±7 days); or when clinically indicated (Approximately 1 year )

  4. Part 1 Dose Escalation: Overall survival (OS): time from date of first dose to death due to any cause

    Measured: Every 12 weeks±14 days after the last dose, until up to 2 years, withdrawal of consent, loss to follow-up, death, or termination of the study, whichever occurs first

  5. Part 1 Dose Escalation: Duration of response (DOR): duration of time a patient is evaluated as either complete response (CR) or partial response (PR) as best response until the first date that the criteria for progression are met, or death.

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

  6. Part 1 Dose Escalation: Disease control rate (DCR): proportion of patients who had a best response rating of complete response (CR) or partial response (PR), or stable disease (SD), which was maintained ≥6 weeks from Day 1 of Cycle 1

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

  7. Part 2 Dose Expansion: Progression-free survival (PFS) duration of time from date of first dose to date of disease progression (according to RECIST v1.1) or death due to any cause, whichever comes first)

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

  8. Part 2 Dose Expansion: Duration of response (DOR) duration of time a patient is evaluated as either CR or PR as best response until the first date that the criteria for progression are met, or death

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

  9. Part 2 Dose Expansion: Incidence of Treatment emergent adverse events (TEAE)

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

  10. Part 2 Dose Expansion: Severity of Treatment emergent adverse events (TEAE) according to the NCI-CTCAE, version 5.0

    Measured: Day 1 through 30 days after last dose, estimated to be 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start25 Feb 2021
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Aug 2023 (estimated)

Resources

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
Sequential
Model description
The dose schedules will be explored in this study (described below): Dose Schedule: IMP7068 administered QD on Days 1-3, Days 8-10 and Days 15-17 on a 21-day cycle. The other Dose Schedules may be explored according to SMC decision. The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. Approximately100 patients each with advanced solid tumor who has exhausted available treatment options with respective biomarker(s) determined by central laboratory will be evaluated. Single dosing will not be performed in the dose-expansion stage of the study.
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768868
Sponsor's protocol ID
IMP7068 - 101
Acronym
WEE1
Status last verified
Feb 2023
First submitted
2 Nov 2020
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP7068 in people with Advanced Solid Tumors, run by Impact Therapeutics, Inc. at 16 sites in 3 countries.

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 7 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Taiwan, 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 Jian Wang (+86 18613056501, Jian.wang@impacttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Dose Escalation: Incidence of treatment emergent adverse events (TEAEs) (time frame: Day 1 through to 30 days after last dose (approximately 4 cycles (84 days plus 30 day follow-up )); Each cycle is 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768868.

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 24 Feb 2023.

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