Solid Tumor, AdultPhase 1/2NCT06524804

A Phase Ib/II Study of BY101298 , an Oral DNA-PK Inhibitor, Combined with Radiotherapy in Patients with Malignant Solid Tumors

A Phase 1/2 study testing BY101298 Capsules, palliative radiotherapy and curative radiotherapy in people with Solid Tumor, Adult, run by Chengdu Baiyu Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Adult
What is being tested?: BY101298 Capsules, palliative radiotherapy and curative radiotherapy
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 15 May 2024to 18 Oct 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

Male or female patients, ≥ 18 and ≤ 75 years of age (inclusive at the time of informed consent).
histologically or cytologically diagnosed solid tumors with indications for radiotherapy after evaluation by investigator (Radiotherapy sites are excluded for patients with primary brain tumors and/or brain metastases). Radiotherapy techniques could be IMRT, IGRT, VMAT or TOMO, except SBRT and SRS.
Cohort 1: Patients with locally advanced/advanced malignant solid tumors who will receive radiotherapy for non-radical purposes, such as radiotherapy for non-oligometastatic tumors.
Cohort 2: Radiotherapy for radical purposes [including, but not limited to, radiotherapy for residual or oligofocal lesions with stable disease or partial response (SD, PR) after systemic treatment, sequential chemoradiotherapy, or not suitable for chemotherapy] with at least one measurable lesion present in the radiation field according to RECIST 1.1 criteria, and radiotherapy dose following each solid tumor radiotherapy guideline. The segmentation method is conventional segmentation.
After obtaining RP2D doses in Phase Ib, extended studies were conducted in specific indications in cohort 1 and Cohort 2, respectively.
Life expectancy ≥ 3 months (cohort 1), and ≥ 6 months (cohort 2).

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The lesions outside the radiation field are tended to be stabilized evaluated by the investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1. (If the symptoms are caused by tumor lesions in the radiotherapy field, ECOG score 0-2 points).
Adequate organ and bone marrow function. Laboratory tests that meet the following criteria within 7 days prior to the first dose of study treatment (without blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc., within 14 days prior to the screening examination).
Understand and be willing to sign written informed consent and be able to follow the study protocol for treatment, visits, and other study procedures.

Who cannot join

Treated with DNA-PK inhibitors.
Potential risks of perforation, bleeding, or other unacceptable risks after treatment evaluated by the investigator.
Radiotherapy sites are primary brain tumors and/or brain metastases.
Previous treatment with any of the following:
Patients who have received systemic chemotherapy, traditional Chinese medicine for anti-tumor indications or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biological therapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug, or those who need to continue receiving these drugs during the study.
Received radiation therapy in the planned radiotherapy field (re-course and multi-course same-site radiotherapy should be excluded in principle).

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The patient has previously received radiotherapy at another site, unless there is no potential risk based on OAR exposure evaluated by the investigator.
Received chinese troditional medicine (Chinese patent medicine) with antitumor indications within 2 weeks prior to initial administration of the investigational drug.
Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug and surgery is scheduled during the study period.
Brain metastasis (except asymptomatic, stable for more than 4 weeks prior to the first dose and not requiring steroid therapy for at least 4 weeks prior to the first dose, no imaging findings of marked edema around the tumor lesion), presence of meningeal metastasis or brainstem metastasis, or presence of spinal cord compression.
Concomitant with other malignancies that may affect the patient's expected life expectancy.
Have undergone bone marrow transplants and/or organ transplants, including allogeneic stem cell transplants.
Toxicities from prior antitumor therapy that have not recovered to CTCAE version 5.0 Grade 1 or less, except CTCAE (V5.0) Grade 2 peripheral neurotoxicity and alopecia of any grade, and other toxicity that has no safety risk evaluated by the investigator.
Patients with third lacunar effusion (such as large pleural effusion, ascites, or pericardial effusion) which is difficult to control and requires repeated drainage.
Serious or uncontrolled diseases as assessed by the investigator, including but not limited to:
Severe or uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg under standardized antihypertensive regimens), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson 's disease, active bleeding, uncontrolled infection.
Cognitive dysfunction, history of psychiatric disorders, other uncontrolled concomitant diseases, alcohol dependence, hormone dependence, or drug abuse.
History of immunodeficiency, including HIV antibody positive, other acquired or congenital immunodeficiency disease, or history of organ transplantation.
HBsAg or HBcAb positive, and peripheral blood HBV DNA titer test ≥ 200 IU/mL or ≥ 1000 copies/mL or above the upper limit of normal value at the study site; HCV antibody test positive, and HCV RNA test above the upper limit of normal value at the study site; treponema pallidum-specific antibody positive.
Clinically serious gastrointestinal dysfunction that may compromise drug intake, transport, or absorption. For example, inability to take oral medication, uncontrollable nausea or vomiting, history of massive gastrointestinal resection, history of gastrointestinal ulcer and gastrointestinal bleeding within 6 months prior to the first dose, untreated recurrent diarrhea, untreated stomach disease requiring long-term use of PPI acid suppressants, Crohn 's disease, ulcerative colitis, etc.
Prior thyroid dysfunction or inability to maintain thyroid function within normal limits even with medical therapy.
Cardiac dysfunction, including any of the following:
Myocardial infarction in past 6 months, heart failure classified as Class II/III/IV according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, and unstable arrhythmia.
Left ventricular ejection fraction LVEF < 50% shown by echocardiography.
QT interval corrected using Fridericia 's formula: QTcF > 470 msec (females), QTcF > 450 msec (males).
Pregnant (positive pregnancy test prior to dosing) or lactating.
History of serious hypersensitivity (e.g., anaphylactic shock) or hypersensitivity to excipients or other ingredients associated with the study drug.
Received live attenuated vaccine within 28 days prior to the first dose.
Other factors considered unsuitable for study enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital
Jinan, Shandong, 250117

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of BY101298 Combined with Radiotherapy in Patients with Malignant Solid Tumors

BY101298 is an innovative DNA-dependent protein kinases (DNA-PK) highly selective small molecule inhibitor. DNA-dependent protein kinases (DNA-PK plays a key role in the NHEJ repair pathway to repair DNA double-strand breaks (DSBs). By inhibiting DNA-PK activity to inhibit DSBs repair, BY101298 may synergistically improve the killing effect on tumor cells, reduce the risk of local recurrence and metastasis, and improve the clinical benefit of cancer patients when combing with radiotherapy.

Primary objective is to assess the safety and tolerability; RP2D. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 and to assess the preliminary efficacy.

Conditions: Solid Tumor, Adult
Being tested: BY101298 Capsules, palliative radiotherapy, curative radiotherapy

What participants receive

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

BY101298 CapsulesDrug
An oral DNA-PK Inhibitor
palliative radiotherapyRadiation
Undergo palliative radiotherapy
BY101298 CapsulesDrug
An oral DNA-PK Inhibitor
curative radiotherapyRadiation
Undergo curative radiotherapy

Study groups in NCT06524804
Study group	Role	What they receive
BY101298 in combination with palliative radiotherapy	Experimental	Patients in Phase I undergo palliative radiotherapy for 5 fractions per week and receive BY101298 PO QD concomitant with radiation therapy. Receives: Drug: BY101298 Capsules; Radiation: palliative radiotherapy
BY101298 in combination with curative radiotherapy	Experimental	Patients in Phase I undergo curative radiotherapy for 5 fractions per week and receive BY101298 PO QD concomitant with radiation therapy. Receives: Drug: BY101298 Capsules; Radiation: curative radiotherapy

What is being measured

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

To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Grade and frequency of adverse events and serious adverse events
Measured: through study completion (an average of 1.5 years)
To assess the maximum tolerated dose (MTD)
Incidence of Dose limiting Toxicities (DLTs)
Measured: through study completion (an average of 1.5 years)
To determine the recommended phase II dose of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
the recommended phase II dose（RP2D）
Measured: through study completion (an average of 1.5 years)

Secondary outcomes (9)

To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
AUC
Measured: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Cmax
Measured: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Cmax,ss
Measured: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Cmin,ss
Measured: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
ORR
Measured: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
DCR
Measured: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
DOR
Measured: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
PFS
Measured: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
OS
Measured: through study completion (an average of 1.5 years)

Timeline

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

15 May 202418 Oct 2024

First posted29 Jul 2024
Study start15 May 2024
Primary completion18 Oct 2024
Study completion18 Oct 2024

Why it stopped: The sponsor adjusts the clinical development strategy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, AdultStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06524804
Sponsor's protocol ID: BY1298-I-02
Status last verified: May 2024
First submitted: 24 Jul 2024
Last updated: 18 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of BY101298 Combined with Radiotherapy in Patients with Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06524804
Acronym / sponsor ID: BY1298-I-02
Conditions: Solid Tumor, Adult
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The sponsor adjusts the clinical development strategy.
Enrolment: 60 participants (actual)
Lead sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 May 2024 (actual)
Primary completion: 18 Oct 2024 (actual)
Study completion: 18 Oct 2024 (actual)
First posted: 29 Jul 2024 (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.

Primary objective is to assess the safety and tolerability; RP2D. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 and to assess the preliminary efficacy.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BY101298 in combination with palliative radiotherapy	Experimental	Drug: BY101298 Capsules, Radiation: palliative radiotherapyPatients in Phase I undergo palliative radiotherapy for 5 fractions per week and receive BY101298 PO QD concomitant with radiation therapy.
BY101298 in combination with curative radiotherapy	Experimental	Drug: BY101298 Capsules, Radiation: curative radiotherapyPatients in Phase I undergo curative radiotherapy for 5 fractions per week and receive BY101298 PO QD concomitant with radiation therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female patients, ≥ 18 and ≤ 75 years of age (inclusive at the time of informed consent).
histologically or cytologically diagnosed solid tumors with indications for radiotherapy after evaluation by investigator (Radiotherapy sites are excluded for patients with primary brain tumors and/or brain metastases). Radiotherapy techniques could be IMRT, IGRT, VMAT or TOMO, except SBRT and SRS.
Cohort 1: Patients with locally advanced/advanced malignant solid tumors who will receive radiotherapy for non-radical purposes, such as radiotherapy for non-oligometastatic tumors.
Cohort 2: Radiotherapy for radical purposes [including, but not limited to, radiotherapy for residual or oligofocal lesions with stable disease or partial response (SD, PR) after systemic treatment, sequential chemoradiotherapy, or not suitable for chemotherapy] with at least one measurable lesion present in the radiation field according to RECIST 1.1 criteria, and radiotherapy dose following each solid tumor radiotherapy guideline. The segmentation method is conventional segmentation.
After obtaining RP2D doses in Phase Ib, extended studies were conducted in specific indications in cohort 1 and Cohort 2, respectively.

Key exclusion criteria (29 listed)

Treated with DNA-PK inhibitors.
Potential risks of perforation, bleeding, or other unacceptable risks after treatment evaluated by the investigator.
Radiotherapy sites are primary brain tumors and/or brain metastases.
Previous treatment with any of the following:
Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug and surgery is scheduled during the study period.

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
BY101298 CapsulesAn oral DNA-PK Inhibitor	Drug	BY101298 in combination with palliative radiotherapy
palliative radiotherapyUndergo palliative radiotherapy	Radiation	BY101298 in combination with palliative radiotherapy
BY101298 CapsulesAn oral DNA-PK Inhibitor	Drug	BY101298 in combination with curative radiotherapy
curative radiotherapyUndergo curative radiotherapy	Radiation	BY101298 in combination with curative radiotherapy

Primary outcome

To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
Grade and frequency of adverse events and serious adverse events
To assess the maximum tolerated dose (MTD)
Time frame: through study completion (an average of 1.5 years)
Incidence of Dose limiting Toxicities (DLTs)
To determine the recommended phase II dose of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
the recommended phase II dose（RP2D）

9 secondary outcomes

To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)
To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors.
Time frame: through study completion (an average of 1.5 years)

Results and safety

The study was stopped early (reason given: The sponsor adjusts the clinical development strategy.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.

Related trials for Solid Tumor, Adult

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

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.

The record lists no contact. Use the official record to reach the sponsor.

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 BY101298 Capsules, palliative radiotherapy and curative radiotherapy in people with Solid Tumor, Adult, run by Chengdu Baiyu Pharmaceutical Co., Ltd. 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 10 inclusion and 29 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: stopped early, as of the sponsor's last update on 18 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 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?

The study was stopped early (reason given: The sponsor adjusts the clinical development strategy.). Results are not available in the source record.

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?

To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors. (time frame: through study completion (an average of 1.5 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 NCT06524804.

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 18 Dec 2024.