Advanced Solid TumorPhase 1/2NCT05258266
A Study to Evaluate the Activity, Safety and Tolerability of ZX-101A in Advanced Solid Tumors
A Phase 1/2 study testing ZX-101A in people with Advanced Solid Tumor, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
ZX-101A-201 is a phase I, open-label, multicenter study which includes dose escalation and dose expansion of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and antitumor activity of ZX-101A in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- 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
- 76 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2022to 30 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who are 18 to 75 years old.
- Minimum life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically or cytologically confirmed inoperable solid tumor subjects and failed standard treatment (PD during treatment or PD after last treatment), or subjects with advanced solid tumors or who cannot tolerate standard treatment and/or currently have no effective standard treatment.
- At least one measurable tumor lesion (according to RECIST V1.1 criteria).
- Systemic chemotherapy has been completed for at least 4 weeks (if the chemotherapy drugs are nitrosoureas and mitomycin C, it should be at least 6 weeks from the last chemotherapy); the anti-tumor monoclonal antibody treatment has been completed at least 4 weeks; small molecule targeted therapy has been completed at least 2 weeks or 5 half-lives of the drug (whichever is longer); Alternative treatment approved by the National Medical Products Administration (NMPA) has been completed for at least 4 weeks.
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- Prior to the first dosing, radiotherapy has been completed for at least 4 weeks, local palliative radiotherapy has been completed for at least 2 weeks, and the acute toxicity caused by previous radiotherapy has recovered to ≤ grade 1.
- Prior cell or gene therapy was completed for at least 4 weeks before the first dose of study drug.
- Acceptable baseline assessment: 1) absolute neutrophil count (ANC) ≥1500 /mm3, platelet count (PLT)≥100K /mm3, and hemoglobin (Hb) ≥90 g/L for blood system (no blood transfusion and blood products or hematopoietic stimulating factor therapy within 14 day); 2) total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN) (≤3.0 × ULN in patients with Gilbert syndrome or liver metastases), alanine aminotransferase (ALT) ≤3.0×ULN, aspartate aminotransferase (AST) ≤3.0×ULN, and albumin ≥2.8 g/dL for liver function; 3) creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥50 ml/min (calculated according to Cockcroft-Gault formula, Ccr is calculated only when creatinine>1.5×ULN) for kidney function; 4) activated partial thromboplastin time (APTT) ≤1.5×ULN and international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN for coagulation.
- Adverse reactions caused by previous treatment recovered to NCI-CTCAE V5.0 standard grade ≤1 before enrollment.
- Female subjects of childbearing age have negative serum pregnancy test results and agree to use effective contraception during the use of the study drug and within 6 months after the last dose.
- Men must agree to no sperm donations during the study and for 3 months after the last dose.
- Be able to understand the requirements of the study, willing to comply with all study procedures and sign the Institutional Review Board (IRB)-approved informed consent.
Who cannot join
- Previous use of PI3K δ/γ dual inhibitors.
- Received any anti-infective vaccine within 4 weeks before the first study drug.
- Received investigational study drug within 4 weeks or 5 half-lives, whichever is longer.
- History of other malignancy within the past 5 years, unless cured by surgery and sustained disease-free survival.
- Active autoimmune disease
- Have used systemic corticosteroids within 2 weeks before the first dosing.
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- Serious medical conditions, including serious heart disease, uncontrolled diabetes, uncontrolled hypertension, active peptic ulcer, active bleeding, etc.
- Gastrointestinal dysfunction, including motility or malabsorption syndromes or inflammatory bowel disease which could limit absorption of study drug.
- Using medications that may lead to prolonged QT during the study period (e.g., antiarrhythmic drugs).
- Central nervous system or meningeal metastasis with clinical symptoms assessed by the investigator to be unsuitable for enrollment.
- Symptomatic ascites or pleural effusion or pericardial effusion.
- Current or past interstitial lung disease, hypersensitivity pneumonitis, pulmonary fibrosis, acute lung disease, etc.
- Active infection requiring systemic therapy.
- Active tuberculosis infection, receiving anti-tuberculosis treatment or received anti-tuberculosis treatment within 1 year before screening.
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA quantification > detection unit upper limit of normal value (ULN), hepatitis C antibody (HCV-Ab) positive and HCV-RNA quantification > detection unit upper limit of normal value, anti-human immunodeficiency virus antibody (Anti - HIV) positive, cytomegalovirus (CMV) infection or viremia, and active syphilis (any of the above). Hepatitis B virus subjects who are stable after 2 weeks of treatment (HBV-DNA quantification less than the lower limit of normal) and cured hepatitis C subjects (with known HCV history and with negative HCV RNA polymerase chain reaction [PCR] test results < 6 months prior to the start of ZX-101A administration) can be enrolled. CMV testing is required to confirm no CMV infection before screening.
- History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or a history of allogeneic bone marrow transplantation, or a history of autologous hematopoietic stem cell transplantation.
- Received a major surgery or have not fully recovered from previous surgery within 4 weeks prior to the first dose of study drug.
- Uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN).
- In the judgment of the investigator, subjects are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
Shun Yang contact
China1 site
Beijing Cancer Hospital
Beijing
Bixia Tang, M.D., +86-13810211044
Bixia Tang, M.D.
About this study
Official title: A Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ZX-101A Monotherapy in Patients With Advanced Solid Tumors
ZX-101A-201 is a phase I, open-label, multicenter study which includes dose escalation and dose expansion of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and antitumor activity of ZX-101A in patients with advanced solid tumors.
Read the detailed description
Phase I includes two parts: dose escalation and dose expansion.
- Part 1. ZX-101A dose escalation: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) or optimal biological administration dose (OBD), and the recommended phase II dose clinical studies (RP2D); 2) To evaluate the pharmacokinetic (PK) characteristics of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the pharmacodynamic (PD) characteristics of ZX-101A in patients with advanced solid tumors.
- Part 2. ZX-101A dose expansion: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors; 2) To evaluate the PK profile of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the PD characteristics of ZX-101A in patients with advanced solid tumors; 5) To explore the effect of ZX-101A on immune cytokines in serum.
- Conditions
- Advanced Solid Tumor
- Being tested
- ZX-101A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-101ADrug
Q.D., oral dosing
| Study group | Role | What they receive |
|---|---|---|
| ZX-101A Dose Level A | Experimental | ZX-101A administered orally at level A once daily in a 28-day cycle Receives: Drug: ZX-101A |
| ZX-101A Dose Level B | Experimental | ZX-101A administered orally at level B once daily in a 28-day cycle Receives: Drug: ZX-101A |
| ZX-101A Dose Level C | Experimental | ZX-101A administered orally at level C once daily in a 28-day cycle Receives: Drug: ZX-101A |
| ZX-101A Dose Level D | Experimental | ZX-101A administered orally at level D once daily in a 28-day cycle Receives: Drug: ZX-101A |
| ZX-101A Dose Level E | Experimental | ZX-101A administered orally at level E once daily in a 28-day cycle Receives: Drug: ZX-101A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining the RP2D of ZX-101A
To assess number of patients experiencing dose-limiting toxicities (DLTs)
Measured: From Day 1 of Cycle 1 until 28 days after the last dose (up to 2 years). Each cycle is 28 days.
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 until 28 days after the last dose (up to 2 years). Each cycle is 28 days.
Secondary outcomes (9)
Objective response rate (ORR)
To evaluate the objective response rate (ORR) as determined by the specific disease response criteria
Measured: Up to 2 years
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
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
Disease control rate (DCR)
To examine the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention
Measured: Up to 2 years
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
Plasma Concentration of ZX-101A
To assess the pharmacokinetic (PK) characteristics of ZX-101A in part 1
Measured: Cycle1Day1 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours; Day18 and Day19 pre-dose; Day20 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8 and 24hours; Cycle2Day1 pre-dose. Each cycle is 28 days.
Plasma Concentration of ZX-101A
To assess the pharmacokinetic (PK) characteristics of ZX-101A in part 2
Measured: Cycle1Day13 and Day14 pre-dose; Day15 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8, 24 hours; Cycle2Day1 pre-dose. Each cycle is 28 days.
MDSC and CD8+ T cell levels in whole blood
To explore the pharmacodynamic (PD) characteristics of ZX-101A
Measured: Cycle1Day1, Cycle2Day1, Cycle3Day1. Each cycle is 28 days.
Cytokines/chemokines levels in serum
To explore the pharmacodynamic (PD) characteristics of ZX-101A in part 2
Measured: Cycle1Day1, Cycle2Day1, Cycle3Day1. 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.
- First posted28 Feb 2022
- Study start9 Mar 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaolin Qin, Ph.D, Study director, Zenshine Pharmaceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258266
- Sponsor's protocol ID
- ZX-101A-201
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ZX-101A Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05258266
- Acronym / sponsor ID
- ZX-101A-201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZX-101A-201 is a phase I, open-label, multicenter study which includes dose escalation and dose expansion of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and antitumor activity of ZX-101A in patients with advanced solid tumors.
Detailed description
Phase I includes two parts: dose escalation and dose expansion.
- Part 1. ZX-101A dose escalation: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) or optimal biological administration dose (OBD), and the recommended phase II dose clinical studies (RP2D); 2) To evaluate the pharmacokinetic (PK) characteristics of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the pharmacodynamic (PD) characteristics of ZX-101A in patients with advanced solid tumors.
- Part 2. ZX-101A dose expansion: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors; 2) To evaluate the PK profile of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the PD characteristics of ZX-101A in patients with advanced solid tumors; 5) To explore the effect of ZX-101A on immune cytokines in serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ZX-101A Dose Level A | Experimental | Drug: ZX-101AZX-101A administered orally at level A once daily in a 28-day cycle |
| ZX-101A Dose Level B | Experimental | Drug: ZX-101AZX-101A administered orally at level B once daily in a 28-day cycle |
| ZX-101A Dose Level C | Experimental | Drug: ZX-101AZX-101A administered orally at level C once daily in a 28-day cycle |
| ZX-101A Dose Level D | Experimental | Drug: ZX-101AZX-101A administered orally at level D once daily in a 28-day cycle |
| ZX-101A Dose Level E | Experimental | Drug: ZX-101AZX-101A administered orally at level E once daily in a 28-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females who are 18 to 75 years old.
- Minimum life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically or cytologically confirmed inoperable solid tumor subjects and failed standard treatment (PD during treatment or PD after last treatment), or subjects with advanced solid tumors or who cannot tolerate standard treatment and/or currently have no effective standard treatment.
- At least one measurable tumor lesion (according to RECIST V1.1 criteria).
Key exclusion criteria (19 listed)
- Previous use of PI3K δ/γ dual inhibitors.
- Received any anti-infective vaccine within 4 weeks before the first study drug.
- Received investigational study drug within 4 weeks or 5 half-lives, whichever is longer.
- History of other malignancy within the past 5 years, unless cured by surgery and sustained disease-free survival.
- Active autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZX-101AQ.D., oral dosing | Drug | ZX-101A Dose Level A, ZX-101A Dose Level B, ZX-101A Dose Level C, ZX-101A Dose Level D, ZX-101A Dose Level E |
Primary outcome
Defining the RP2D of ZX-101A
Time frame: From Day 1 of Cycle 1 until 28 days after the last dose (up to 2 years). Each cycle is 28 days.
To assess number of patients experiencing dose-limiting toxicities (DLTs)
To examine the incidence of clinical and laboratory adverse events after multiple doses of ZX-101A
Time frame: From Day 1 of Cycle 1 until 28 days after the last dose (up to 2 years). Each cycle is 28 days.
Incidence of treatment-emergent adverse events [safety and tolerability]
9 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Plasma Concentration of ZX-101A
Time frame: Cycle1Day1 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours; Day18 and Day19 pre-dose; Day20 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8 and 24hours; Cycle2Day1 pre-dose. Each cycle is 28 days.
Plasma Concentration of ZX-101A
Time frame: Cycle1Day13 and Day14 pre-dose; Day15 pre-dose and post-dose 0.5, 1, 2, 4, 6, 8, 24 hours; Cycle2Day1 pre-dose. Each cycle is 28 days.
MDSC and CD8+ T cell levels in whole blood
Time frame: Cycle1Day1, Cycle2Day1, Cycle3Day1. Each cycle is 28 days.
Cytokines/chemokines levels in serum
Time frame: Cycle1Day1, Cycle2Day1, Cycle3Day1. Each cycle is 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shun Yang contact
Xiaolin Qin, Ph.D study director
Zenshine Pharmaceutical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZX-101A in people with Advanced Solid Tumor, run by Nanjing Zenshine Pharmaceuticals at 1 site 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 19 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 14 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Luo (+86-15951876049, luoli@zenshine-pharma.com), or a site near the patient. 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 until 28 days after the last dose (up to 2 years). Each cycle is 28 days.). 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?
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 14 Mar 2022.