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Non Hodgkin LymphomaPhase 1/2NCT05269940

A Study to Evaluate Activity, Safety and Tolerability of ZX-101A in Relapsed/Refractory Hematological Malignancies

A Phase 1/2 study testing ZX-101A in people with Non Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Nanjing Zenshine Pharmaceuticals at 3 sites in China.

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

ZX-101A-202 is a Phase I, open-label, multicenter study, a single-agent dose-escalation and dose-expansion study of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics, efficacy and antitumor activity of ZX-101A in patients with relapsed/refractory hematological… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ZX-101A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
17 Feb 2022to 5 Jul 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

  • Males and females who are ≥ 18 years old
  • Minimum life expectancy ≥ 3 months (determined by investigator assessment)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to1.
  • Histopathological and cytological confirmed diagnosis of hematological malignancies.
  • Phase I dose expansion and phase II studies require at least 1 measurable lesion, including cutaneous T-cell lymphoma [CTCL] without evidence of skin involvement.
  • Acceptable bone marrow function.
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  • Acceptable organ function: creatinine clearance ≥ 60 mL/min calculated according to institutional standard practice assessment (according to the Cockcroft-Gault formula) for kidney function; AST and ALT ≤ 2.5 x upper limit of normal (ULN) (AST and ALT ≤ 4 x ULN in subjects with liver involvement); total bilirubin ≤ 1.5 x ULN (total bilirubin ≤ 3 in subjects with Gilbert syndrome ×ULN) for liver function.
  • No transfusion or cytokine support for ≥ 2 weeks before first dosing.
  • Ability to swallow oral medication.
  • Negative serum pregnancy test in women of childbearing potential at screening.
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months (females) or 3 months (males) after the last dose of ZX-101A.
  • Men must agree to no sperm donation during the study and for 3 months after the last dose of ZX-101A.
  • Understands the requirements of the study, is willing to comply with all study procedures and signed the IRB-approved informed consent.

Who cannot join

  • Previous use of PI3K δ/γ dual inhibitors
  • Received approved anti-cancer drugs within 28 days (42 days for nitrosoureas) or 5 half-lives, whichever is longer.
  • Radiation treatment within 2 weeks prior to first dose of study treatment.
  • Received investigational study drug within 28 days (or 5 half-lives, whichever is longer).
  • Received organ transplantation in the past (hematopoietic stem cell transplantation in the past is allowed).
  • Major surgery within 28 days prior to the first dose of study drug
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  • Has not recovered from adverse events from prior anti-cancer treatment (with exception of alopecia).
  • Concurrent participation in another therapeutic treatment trial.
  • Those who have been vaccinated with live vaccines or live attenuated vaccines within 30 days before the first administration, and seasonal influenza vaccines without live viruses are allowed.
  • Received warfarin or factor Xa inhibitor within 5 half-lives before the first dose of study drug.
  • With central nervous system (CNS) involvement or active leptomeningeal disease.
  • History of other malignancy within the past 5 years, unless cured by surgery and sustained disease-free survival.
  • CLL with Richter transformation.
  • Active autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
  • Chronic immunosuppression conditions.
  • QTcF interval > 480 msec; echocardiographic detection of left ventricular ejection fraction < 45%.
  • Uncontrolled systemic diseases, including myocardial infarction or bypass, stent surgery, or other heart disease, in the judgement of the investigator, inappropriate for enrollment.
  • Active uncontrolled infection within 14 days before first dosing.
  • Active infection of Hepatitis B virus or hepatitis C virus; history of HIV infection.
  • History of drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic obstruction due to gallstones, cirrhosis or portal vein history of hypertension.
  • History of interstitial lung disease, hypersensitivity pneumonitis, pulmonary fibrosis, radiation pneumonitis and severe pulmonary function impairment, or other pulmonary diseases that significantly affect the safety or compliance of patients after being evaluated and included by the investigator.
  • Gastrointestinal dysfunction, including motility or malabsorption syndromes or inflammatory bowel disease which could limit absorption of study drug.
  • Any concurrent uncontrolled illness, including mental illness or substance abuse.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Hunan Tumor Hospital

    Changsha, Hunan

  • Anhui Medical University No.4 Affiliated Hospital

    Hefei, Anhui

  • Wuhan Union Hospital

    Wuhan, Hubei

Other trials in China

About this study

Official title: A Phase I/II Study Evaluating ZX-101A in Patients with Relapsed/Refractory Hematological Malignancies

ZX-101A-202 is a Phase I, open-label, multicenter study, a single-agent dose-escalation and dose-expansion study of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics, efficacy and antitumor activity of ZX-101A in patients with relapsed/refractory hematological malignancies.

Read the detailed description

Phase I includes two parts: dose escalation and dose expansion. It's mainly to explore the safety and tolerability of ZX-101A in patients with relapsed/ refractory hematological malignancies [Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), indolent NHL, and other NHL subtypes], and to determine RP2D.

  • Part 1. ZX-101A dose escalation
  • Part 2. ZX-101A dose expansion in two specific types of lymphoma, i.e. PTCL /CTCL or one B-iNHL.
Being tested
ZX-101A
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Peripheral

What participants receive

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

  • ZX-101ADrug

    oral dosing, once daily

Study groups in NCT05269940
Study groupRoleWhat they receive
ZX-101A Dose Level AExperimentalZX-101A administered orally at level A once daily
Receives: Drug: ZX-101A
ZX-101A Dose Level BExperimentalZX-101A administered orally at level B once daily
Receives: Drug: ZX-101A
ZX-101A Dose Level CExperimentalZX-101A administered orally at level C once daily
Receives: Drug: ZX-101A
ZX-101A Dose Level DExperimentalZX-101A administered orally at level D once daily
Receives: Drug: ZX-101A
ZX-101A Dose Level EExperimentalZX-101A administered orally at level E once daily
Receives: Drug: ZX-101A

What is being measured

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

  1. Defining the RP2D of ZX-101A

    To assess number of patients experiencing dose-limiting toxicities (DLTs)

    Measured: From Day 1 of Cycle 1 (each cycle is 28 days) until 28 days after the last dose (up to 2 years)

  2. To examine the incidence of clinical and laboratory adverse events after multiple doses of ZX-101A

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: From Day 1 of Cycle 1 (each cycle is 28 days) until 28 days after the last dose (up to 2 years)

Secondary outcomes (6)

  1. Objective response rate (ORR)

    To evaluate the objective response rate (ORR) as determined by the specific disease response criteria

    Measured: Up to 2 years

  2. Duration of response (DoR)

    To examine the duration of response (DoR), defined as time from the date of first documentation of response to the date of the first documentation of progressive disease (PD), or death due to any cause

    Measured: Up to 2 years

  3. Progression free survival (PFS)

    To examine the the progression free survival (PFS), defined as time from the date of first dose of study treatment to the first date of documentation of PD, or death due to any cause

    Measured: Up to 2 years

  4. Overall survival (OS)

    To examine the overall survival (OS), defined as time from the date of first dose of study treatment to death due to any cause

    Measured: Up to 2 years

  5. Plasma Concentration of ZX-101A

    To assess the pharmacokinetic (PK) characteristics of ZX-101A and its major metabolites (if applicable) in part 1

    Measured: Cycle1Day1 pre-dose and post-dose 0.5, 1 , 2, 4, 6, 8, 24, 48, 72, 96 hours; Cycle1Day13, Day14, Day15 pre-dose and post-dose 0.5, 1, 2, 4 , 6, 8 and 24 hours; Cycle2Day1 pre-dose. Each cycle is 28 days.

  6. Phospho-AKT (p-AKT) levels in whole blood

    To evaluate the differences phospho-AKT (p-AKT) levels in whole blood before and after single oral dose of ZX-101A.

    Measured: Cycle1Day1 pre-dose and post-dose 1 hour and 24 hours. Each Cycle is 28 days.

Timeline

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

  1. First posted8 Mar 2022
  2. Study start17 Feb 2022
  3. Primary completion24 Jan 2023
  4. Study completion5 Jul 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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269940
Sponsor's protocol ID
ZX-101A-202
Status last verified
Nov 2024
First submitted
23 Jan 2022
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ZX-101A in people with Non Hodgkin Lymphoma and Peripheral T Cell Lymphoma, run by Nanjing Zenshine Pharmaceuticals at 3 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 13 inclusion and 23 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 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

Defining the RP2D of ZX-101A (time frame: From Day 1 of Cycle 1 (each cycle is 28 days) until 28 days after the last dose (up to 2 years)). The study lists 2 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 NCT05269940.

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 13 Nov 2024.

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