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MalignancyPhase 1/2NCT03997968

A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors

A Phase 1/2 study testing CYT-0851, CYT-0851 in combination with gemcitabine and CYT-0851 in combination with capecitabine in people with Malignancy and Non-hodgkin Lymphoma, run by Cyteir Therapeutics, Inc. at 16 sites in United States.

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 clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignancy, Non-hodgkin Lymphoma, Multiple Myeloma
What is being tested?
CYT-0851, CYT-0851 in combination with gemcitabine and CYT-0851 in combination with capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
16 sitesUnited States
Study dates
9 Oct 2019to 20 Dec 2024
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

None listed.

Who cannot join

  • Medical Conditions
  • Known history of HIV
  • Known history of viral hepatitis B unless HBV viral load is below the limit of quantification and off viral suppressive therapy
  • Know history of hepatitis C unless antiviral treatment with curative intent completed and HCV viral load is below the limit of quantification.
  • Myocardial infarction or stroke within 6 months
  • Uncontrolled hypertension (systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) >100 on maximal medical therapy)
Show all 46Show fewer
  • History of interstitial pulmonary disease
  • Unresolved pneumonitis
  • Grade ≥ 3 neuropathy
  • Known active central nervous system (CNS) metastases. Subjects with previously treated CNS metastases may participate as long as clinically and radiologically stable for at least 4 weeks after treatment, have no evidence of new or enlarging lesions and are off steroids and asymptomatic for 28 days prior to dosing with study medication
  • Known history of meningeal involvement or meningeal carcinomatosis
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to screening visit
  • Presence of clinically significant cataracts
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancy that is in remission or stable and for which patients have not been on active anti-cancer therapy for 2 years
  • Pregnant or lactating. If β-HCG is elevated, eligible if ultrasound confirms absence of a pregnancy.
  • Dementia or significantly altered metal status
  • Bowel obstruction requiring medical management less than 4 weeks prior to screening
  • Inability to tolerate oral intake that includes 2 full meals per day (or equivalent) or swallow pills.
  • Recurrent ascites requiring paracentesis more frequently than every 4 weeks or within 14 days of screening.
  • Weight loss of more than 10% over the preceding 3 months prior to screening
  • Prior/Concomitant Therapy
  • Prior allogeneic stem cell transplant
  • On systemic antibiotic, antifungal or anti-viral therapy
  • White blood cell (WBC) growth factors administered within 14 days of screening visit
  • Cancer therapy within 14 days prior to treatment with study drug
  • On narrow therapeutic index medications that are sensitive substrates of CYP3A, P-gp or BCRP (or caution is warranted with approval by the Sponsor).
  • On any drug known to prolong QTc interval (eg, certain antiarrhythmic, antimicrobials) that cannot be discontinued or interrupted 72 hours before the Day 1 dose through Day 2, and 72 hours before the Day 15 dose until Day 16 (BID dosing) or the Day 22 dose until Day 23 (QD dosing), in Cycle 1 (see Section 7.6.1 for a list of drugs).
  • On systemic corticosteroid treatment for non-tumor indication at a daily dose equivalent to >10mg of Prednisone
  • Prior/Concurrent Clinical Study Experience a. Participation in another clinical trial (unless in the observation phase, or an observational study), or exposure to any investigational agent within 14 days prior to treatment with study drug
  • Laboratory assessments
  • Complete blood count (CBC):
  • Monotherapy and Chemotherapy Combinations 1 and 2:
  • ANC < 1.0 × 10^9/L
  • PLT < 75 × 10^9/L
  • Hgb < 9.0 g/dL
  • Chemotherapy Combination Group 3:
  • 1) ANC < 1.5 × 10^9/L 2) PLT < 100 × 10^9/L 3) Hgb < 9.0 g/dL
  • Monotherapy and Chemotherapy Combination Groups 1 and 2:
  • Calculated Creatinine clearance (Cockcroft-Gault) < 40 mL/min
  • Chemotherapy Combination Group 3:
  • Calculated Creatinine clearance (Cockcroft-Gault) < 50 mL/min c. Hepatic function
  • AST > 2.0 × ULN
  • ALT > 2.0 × ULN d. Total bilirubin > 1.5 x ULN e. Albumin < 2.8 g/dL 5. ECG Exclusion a. Screening QTc interval > 450 milliseconds for males and QTc > 470 ms for females (corrected by Fridericia) 6. Other Exclusions
  • Unwilling or unable to make all planned study visits
  • Unwilling or unable to provide a recent biopsy or bone marrow sample prior to enrollment and during study; Note: certain exceptions may be permitted allowing archival specimens prior to treatment or for subjects where a specimen is not required for biomarker positive testing
  • Significant medical diseases or conditions, as assessed by the Investigators and Cyteir that would substantially increase the risk-benefit ratio of participating in the study. This includes but is not limited to acute myocardial infarction, arterial thrombosis, significant gastrointestinal bleed, or unstable angina within the last 6 months uncontrolled diabetes mellitus, current active infections, severely immunocompromised state, and congestive heart failure New York Heart Association (NYHA) Class III-IV, left ventricular ejection fraction (LVEF) < 40% d: Chemotherapy Combination Group 3 only: known history of dhydropyrimidine dehydrogenase deficiency

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • John Theurer Cancer Center at HUMC

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • NYU Langone Health

    New York, New York, 10016

  • Oklahoma University-Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California San Francisco

    San Francisco, California, 94158

  • Florida Cancer Specialists and Research Institute

    Sarasota, Florida, 34232

  • University of Washington Seattle Cancer Center

    Seattle, Washington, 98109

  • Stanford Comprehensive Cancer Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors

This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.

Being tested
CYT-0851, CYT-0851 in combination with gemcitabine, CYT-0851 in combination with capecitabine, CYT-0851 in combination with rituximab and bendamustine
Keywords
Oral MCT-inhibitor; refractory; B-cell; solid tumor, cancer
Medical subject headings
Neoplasms, Lymphoma, Non-Hodgkin, Multiple Myeloma, Breast Neoplasms, Ovarian Neoplasms, Sarcoma, Head and Neck Neoplasms, Lymphoma, Mantle-Cell

What participants receive

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

  • CYT-0851Drug

    Part A and B: Daily oral doses of CYT-0851 for 28 day cycles

  • CYT-0851 in combination with gemcitabineDrug

    Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine

  • CYT-0851 in combination with capecitabineDrug

    Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine

  • CYT-0851 in combination with rituximab and bendamustineDrug

    Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab and bendamustine

Study groups in NCT03997968
Study groupRoleWhat they receive
CYT-0851 dose escalationExperimentalPart A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles
Receives: Drug: CYT-0851
CYT-0851 dose expansionExperimentalPart B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles
Receives: Drug: CYT-0851
CYT-0851 and rituximab and bendamustineExperimentalPart C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle
Receives: Drug: CYT-0851; Drug: CYT-0851 in combination with rituximab and bendamustine
CYT-0851 and gemcitabineExperimentalPart D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
Receives: Drug: CYT-0851; Drug: CYT-0851 in combination with gemcitabine
CYT-0851 and capecitabineExperimentalPart E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle
Receives: Drug: CYT-0851; Drug: CYT-0851 in combination with capecitabine

What is being measured

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

  1. Part A: Incidence of dose limiting toxicity

    Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose

    Measured: 28 Days

  2. Part B: Objective response rate

    clinical benefit as determined by investigator assessments of tumor response

    Measured: 24 Weeks

  3. Part C: Incidence of dose limiting toxicity

    Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with rituximab and bendamustine

    Measured: 28 Days

  4. Part D: Incidence of dose limiting toxicity

    Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with gemcitabine

    Measured: 28 Days

  5. Part E: Incidence of dose limiting toxicity

    Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with capecitabine

    Measured: 21 Days

Secondary outcomes (18)

  1. Part A: Incidence of adverse events and other safety measures

    incidence of adverse events changes in laboratory parameters, vital signs and ECGs

    • Establish the PK of CYT-0851 Evaluate the type and frequency of adverse events

    Measured: 28 Days

  2. Part C: Incidence of adverse events and other safety measures

    incidence of adverse events changes in laboratory parameters, vital signs and ECGs

    • Establish the PK of CYT-0851 Evaluate the type and frequency of adverse events

    Measured: 28 Days

  3. Part D: Incidence of adverse events and other safety measures

    incidence of adverse events changes in laboratory parameters, vital signs and ECGs

    • Establish the PK of CYT-0851 Evaluate the type and frequency of adverse events

    Measured: 28 Days

  4. Part E: Incidence of adverse events and other safety measures

    incidence of adverse events changes in laboratory parameters, vital signs and ECGs

    • Establish the PK of CYT-0851 Evaluate the type and frequency of adverse events

    Measured: 21 Days

  5. Part A: Assessment of pharmacokinetic parameters

    Summarize PK parameters including Cmax, AUC and tmax

    Measured: Phase 1: 12 months

  6. Part C: Assessment of pharmacokinetic parameters

    Summarize PK parameters including Cmax, AUC and tmax

    Measured: Phase 1: 12 months

  7. Part D: Assessment of pharmacokinetic parameters

    Summarize PK parameters including Cmax, AUC and tmax

    Measured: Phase 1: 12 months

  8. Part E: Assessment of pharmacokinetic parameters

    Summarize PK parameters including Cmax, AUC and tmax

    Measured: Phase 1: 12 months

  9. Part B: Assessment of pharmacokinetic parameters

    Summarize PK parameters including Cmax, AUC and tmax

    Measured: Phase 1: 12 months

  10. Part A: Objective response rate

    clinical activity as assessed by investigator assessment of objective response and duration of response

    Measured: 24 months

  11. Part C: Objective response rate

    clinical activity as assessed by investigator assessment of objective response and duration of response

    Measured: 24 months

  12. Part D: Objective response rate

    clinical activity as assessed by investigator assessment of objective response and duration of response

    Measured: 24 months

  13. Part E: Objective response rate

    clinical activity as assessed by investigator assessment of objective response and duration of response

    Measured: 24 months

  14. Part B: Anti-tumor activity and by DOR

    Antitumor activity as assessed by duration of response

    Measured: 24 months

  15. Part B: Anti-tumor activity by PFS

    Antitumor activity as assessed by progression free survival

    Measured: 24 months

  16. Part B: Anti-tumor activity by DCR

    Antitumor activity as assessed by disease control rate

    Measured: 24 months

  17. Part B: Anti-tumor activity by OS

    Antitumor activity as assessed by overall survival

    Measured: 24 months

  18. Part B: Safety assessment

    Safety as determined by incidence of AEs and SAEs and changes in laboratory, vitals and ECG findings

    Measured: 24 months

Timeline

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

  1. First posted25 Jun 2019
  2. Study start9 Oct 2019
  3. Primary completion30 Nov 2024
  4. Study completion20 Dec 2024

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
Sequential
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997968
Sponsor's protocol ID
CYT-0851-01
Status last verified
Dec 2024
First submitted
24 Jun 2019
Last updated
24 Dec 2024
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 1/2 study testing CYT-0851, CYT-0851 in combination with gemcitabine and CYT-0851 in combination with capecitabine in people with Malignancy and Non-hodgkin Lymphoma, run by Cyteir Therapeutics, Inc. at 16 sites in United States.

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 0 inclusion and 46 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 24 Dec 2024. 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. 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?

Part A: Incidence of dose limiting toxicity (time frame: 28 Days). The study lists 5 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 NCT03997968.

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 Dec 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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