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Advanced Refractory Solid TumorsPhase 1/2NCT04200404

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

A Phase 1/2 study testing CS1001 and Regorafenib in people with Advanced Refractory Solid Tumors, run by CStone Pharmaceuticals at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Refractory Solid Tumors
What is being tested?
CS1001 and Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteAustralia
Study dates
13 Dec 2019to 18 Aug 2021
Phase
Phase 1/2
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

  • All participants must have unresectable advanced or metastatic tumors that have histologic or cytologic documentation confirmed.
  • Participant must have at least one measurable lesion by CT or MRI per RECIST 1.1; radiographic tumor assessment should be performed within 28 days prior to initiation of study treatment.
  • ECOG performance status score of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • Fresh or archival tumor tissue must be provided for PD-L1 expression testing in selected cohorts.
  • Adequate organ function
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  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. Either Female or male participants must agree to use adequate contraceptive measures from signing informed consent and for 180 days after last investigational product administration, except for a participant with documented surgical sterilization or a postmenopausal female.
  • Any toxic effects of prior anti-cancer therapy or surgical procedures resolved to baseline severity or NCI-CTCAE version 5 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
  • Subjects with hepatitis B virus (HBV) infection must have HBV DNA < 2000 IU/mL at screening, and requires continue anti-HBV treatment in the study

Who cannot join

  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
  • Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis that is either symptomatic or untreated.
  • Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
  • Significant history of cardiac disease within 6 months prior to Day 1 of Cycle 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication, or left ventricular ejection fraction (LVEF) is below 50%.
  • History or evidence of poorly controlled arterial hypertension.
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  • Any serious or uncontrolled medical disorder or active infection may increase the risk associated with study participation or dose.
  • Administration of drugs known as strong CYP3A4 inducers or strong CYP3A4 inhibitors and the last dose was given in < 5 half-lives from the first investigational product administration.
  • Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 28 days prior to the start of study treatment.
  • Other inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

Other trials in Australia

About this study

Official title: A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)

Being tested
CS1001, Regorafenib

What participants receive

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

  • CS1001Drug

    One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).

  • RegorafenibDrug

    Also called BAY 73-4506

    One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.

Study groups in NCT04200404
Study groupRoleWhat they receive
Phase Ib armExperimentalarms 1. Phase Ib: advanced or refractory solid tumors;
Receives: Drug: CS1001; Drug: Regorafenib
Phase II armExperimentalarms 2.Phase II: subjects with tumor of specific types
Receives: Drug: CS1001; Drug: Regorafenib

What is being measured

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

  1. Phase Ib (Safety Evaluation): Number of participants with adverse events

    Measured: Baseline up to 90 days post last dose, up to 2 years

  2. Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT)

    Measured: Baseline up to 90 days post last dose, up to 2 years

  3. Phase II (Efficacy Expansion): Objective response rate (ORR)

    Measured: Up to 2 years

Secondary outcomes (14)

  1. Phase Ib (Safety Evaluation): Objective response rate (ORR)

    Measured: Up to 2 years

  2. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR)

    Measured: Up to 2 years

  3. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS)

    Measured: Up to 2 years

  4. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR)

    Measured: Up to 2 years

  5. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS)

    Measured: Up to 2 years

  6. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Occurrence of anti-CS1001 antibody

    Measured: From first dose to 30 days after last dose, up to 2 years

  7. Phase II (Efficacy Expansion): : Number of participants with adverse events

    Measured: Baseline up to 90 days post last dose, up to 2 years

  8. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Area under the plasma concentration-time curve (AUC)0-t of CS1001

    Measured: From first dose to 30 days after last dose, up to 2 years

  9. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Maximum plasma concentration (Cmax) of CS1001

    Measured: From first dose to 30 days after last dose, up to 2 years

  10. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Time to reach maximum plasma concentration (Tmax) of CS1001

    Measured: From first dose to 30 days after last dose, up to 2 years

  11. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Terminal elimination half-life (t1/2) of CS1001

    Measured: From first dose to 30 days after last dose, up to 2 years

  12. Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Clearance at Steady State (CLss) of CS1001

    Measured: From first dose to 30 days after last dose, up to 2 years

  13. Phase Ib (Safety Evaluation): Maximum plasma concentration (Cmax) of regorafenib

    Measured: From first dose to 30 days after last dose, up to 2 years

  14. Phase Ib (Safety Evaluation): Minimum plasma concentration (Cmin) of regorafenib

    Measured: From first dose to 30 days after last dose, up to 2 years

Timeline

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

  1. First posted16 Dec 2019
  2. Study start13 Dec 2019
  3. Primary completion13 May 2021
  4. Study completion18 Aug 2021

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200404
Sponsor's protocol ID
CS1001/Regorafenib-101
Status last verified
May 2022
First submitted
13 Dec 2019
Last updated
6 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CS1001 and Regorafenib in people with Advanced Refractory Solid Tumors, run by CStone Pharmaceuticals at 1 site in Australia.

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 9 inclusion and 10 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 6 May 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 Australia. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase Ib (Safety Evaluation): Number of participants with adverse events (time frame: Baseline up to 90 days post last dose, up to 2 years). The study lists 3 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 NCT04200404.

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 6 May 2022.

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