MetastasisPhase 1NCT05002140
Trial of XRD-0394, a Kinase Inhibitor, in Combination With Palliative Radiotherapy in Advanced Cancer Patients
A Phase 1 study testing XRD-0394 and Palliative radiotherapy in people with Metastasis and Locally Advanced Solid Tumor, run by XRad Therapeutics Inc at 2 sites in United States.
Trial summary
XRD-0394 is a novel, potent, oral, small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK) that has selectivity compared with other phosphatidylinositol 3-kinase-related kinase (PIKK) family enzymes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis, Locally Advanced Solid Tumor, Recurrent Cancer
- What is being tested?
- XRD-0394 and Palliative 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
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2021to 21 Jul 2023
- Phase
- Phase 1
- 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
- Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Subjects with locally advanced or recurrent (non-metastatic) cancer for whom palliative RT is indicated may also be enrolled.
- Scheduled to receive palliative RT delivered as 4 Gray × 5 daily fractions at the discretion of the treating radiation oncologist. The radiation plan should be designed to optimally limit the radiation dose delivered to normal tissues using conformal treatment plans and protocol-specified limits.
- One or more of the following sites of metastasis:
- Skin
- Subcutaneous or soft tissue
- Any other site that will allow the radiation dose to normal structures to remain within protocol-specified dosing limits.
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- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Male or female subjects at least 18 years of age who are willing and able to provide written informed consent.
- Other protocol-defined criteria may apply
Who cannot join
- Prior radiotherapy to the same region within the last 6 months.
- Subjects who are currently receiving palliative RT for brain metastases. Subjects who have brain metastases may participate in this trial, if they are receiving palliative RT for cancer in a location other than the brain.
- For subjects with cancers involving the spinal cord, the length of the spinal cord requiring palliative treatment must be 10 cm or less.
- Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <0.7 × 10^9/L, or platelets <80 × 10^9/L .
- History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
- Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2.
Show all 14Show fewer
- Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy within 14 days of first XRD-0394 dose. These treatments should also be held for a minimum of 14 days after completion of RT.
- Subjects receiving bleomycin within 30 days of the first dose of XRD-0394.
- Subjects receiving treatment with any drug that is a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 enzyme activity or an inhibitor of breast cancer resistance protein (BCRP) within 14 days or 5 half-lives prior to screening (whichever is longer). In particular,
- Glucocorticoids are inducers of CYP3A4. Therefore, dexamethasone, prednisone, or other glucocorticoids should not be administered within 14 days or 5 half-lives prior to screening (whichever is longer) and should only be initiated after the course of palliative RT is complete (and at least 24 hours after the administration of XRD-0394).
- Gefitinib and imatinib are inhibitors of BCRP. Therefore, these agents should not be administered within 14 days or 5 half-lives prior to screening (whichever is longer) and should be held for a minimum of 14 days after completion of RT.
- Participation in another investigational study of an unapproved drug or device or treatment with another ATM, DNA-PK, or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394.
- Subjects who are pregnant or breast-feeding.
- Subjects with a QTc interval >450 msec (calculated using Fridericia's QT correction formula) at screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford Clinical Cancer Center
Stanford, California, 94305
About this study
Official title: A Phase 1, Open-Label, Dose-Finding, Pharmacokinetic, and Pharmacodynamic Study of XRD-0394 in Subjects With Metastatic, Locally Advanced, or Recurrent Cancer Receiving Palliative Radiotherapy
XRD-0394 is a novel, potent, oral, small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK) that has selectivity compared with other phosphatidylinositol 3-kinase-related kinase (PIKK) family enzymes. This is a first-time-in-human study, which means that it is the first time the study drug is being used in humans. The purpose of the study is to evaluate the safety and tolerability of single doses of XRD-0394 administered with palliative radiotherapy (RT) to subjects with metastatic, locally advanced, or recurrent cancer. The pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of single-dose XRD-0394 administered in combination with palliative RT will also be characterized.
Read the detailed description
This is a Phase 1, multicenter, open-label, dose-finding, PK and PD study of XRD-0394 in subjects with metastatic, locally advanced, or recurrent cancer receiving palliative RT. The study will evaluate single-dose PK of XRD-0394 administered to serial cohorts of subjects with the intent of identifying an oral dose that achieves plasma drug concentrations within a specified therapeutic range. Once target plasma concentrations of XRD-0394 are reached, one or more PD cohorts of subjects will be enrolled in order to demonstrate inhibition of radiation-induced ATM activity in tumor biopsy samples from subjects who received the selected dose(s).
Single Dose Escalation: Eligible subjects will be enrolled in serial cohorts to evaluate the PK of single ascending doses of XRD-0394. Dose escalation of XRD-0394 will proceed based on a standard 3+3 design. The starting dose of XRD-0394 will be 40 mg, followed by planned doses of 80 mg and 160 mg. Following administration of a single-dose of XRD-0394 and completion of RT, subjects will be evaluated for the occurrence of dose-limiting toxicities (DLTs). The available PK and safety data for each cohort will be reviewed at the conclusion of the DLT evaluation period before the decision to escalate to the next dose is made. The evaluation of additional doses of XRD-0394 will be determined based on the safety and PK data collected at completed dose levels. Dose escalation may continue until the objectives of the study are met and/or the maximum tolerated dose (MTD) of XRD-0394 is reached. PK samples for measurement of plasma concentrations of XRD-0394 will be collected pre-dose and at specified time points following XRD-0394 administration. Safety and tolerability of each XRD-0394 dose level will be evaluated by assessment of treatment-emergent adverse events (TEAEs), DLTs, and discontinuations due to TEAEs. A Safety Monitoring Committee (SMC) will be used during the study to monitor subject safety and evaluate potential DLTs.
Pharmacodynamic Assessment: The dose identified to produce plasma drug concentrations of XRD-0394 within a targeted therapeutic range will be further evaluated in separate PD cohort(s) of subjects. Subjects enrolled in a PD cohort must have a target tumor with a soft tissue component that is accessible for biopsy and must agree to undergo 1 biopsy during their RT regimen. PK samples for measurement of plasma concentrations of XRD-0394 will be collected from all subjects at pre-dose and at specified time points after XRD-0394 administration. Safety and tolerability of XRD-0394 will be evaluated by assessment of TEAEs.
- Conditions
- Metastasis, Locally Advanced Solid Tumor, Recurrent Cancer
- Being tested
- XRD-0394, Palliative radiotherapy
- Keywords
- Ataxia telangiectasia mutated kinase, ATM, DNA-PK, DNA-dependent protein kinase, Dual inhibitor, Cancer, Palliative radiotherapy, Single dose
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XRD-0394Drug
Single ascending dose
Palliative radiotherapyRadiation
4 Gy × 5 daily fractions
| Study group | Role | What they receive |
|---|---|---|
| XRD-0394 40 mg | Experimental | Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen Receives: Drug: XRD-0394; Radiation: Palliative radiotherapy |
| XRD-0394 80 mg | Experimental | Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen Receives: Drug: XRD-0394; Radiation: Palliative radiotherapy |
| XRD-0394 160 mg | Experimental | Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen Receives: Drug: XRD-0394; Radiation: Palliative radiotherapy |
| XRD-0394 (Dose TBD) | Experimental | Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT. A single biopsy will be performed in each subject (either after RT alone or after XRD-0394 and RT). Receives: Drug: XRD-0394; Radiation: Palliative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with at least 1 dose-limiting toxicity (DLT)
Measured: 28 days post-completion of RT
Number of subjects experiencing treatment-emergent adverse events (TEAE), serious TEAEs, TEAEs leading to discontinuation of RT, and TEAEs leading to death
Measured: 28 days post-completion of RT
Secondary outcomes (8)
Identification of dose(s) of XRD-0394 that achieve concentrations within protocol-specified range
Measured: Day 2 of RT regimen
Determination of maximum plasma concentration (Cmax) after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Determination of plasma concentrations at 1 to 4 hours post-dose after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Determination of time to maximum plasma concentration (tmax) after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Determination of area under the plasma concentration versus time curve from zero to the last sampling time (AUC0-t) after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Determination of area under the plasma concentration versus time curve from zero to infinity (AUC0-∞) after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Determination of terminal half-life (t1/2) after a single dose of XRD-0394
Measured: Day 2 through Day 5 of RT regimen
Change in radiation-induced phosphorylated Krüppel-associated box domain (KRAB)-associated protein 1 (pKAP1) in tumor biopsy samples
Measured: Day 1 through Day 5 of RT regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start24 Aug 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- XRad Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002140
- Sponsor's protocol ID
- X0394-001
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Finding, Pharmacokinetic, and Pharmacodynamic Study of XRD-0394 in Subjects With Metastatic, Locally Advanced, or Recurrent Cancer Receiving Palliative Radiotherapy
- ClinicalTrials.gov ID
- NCT05002140
- Acronym / sponsor ID
- X0394-001
- Conditions
- Metastasis, Locally Advanced Solid Tumor, Recurrent Cancer
- Keywords
- Ataxia telangiectasia mutated kinase, ATM, DNA-PK, DNA-dependent protein kinase, Dual inhibitor, Cancer, Palliative radiotherapy, Single dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- XRad Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 12 Aug 2021 (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.
XRD-0394 is a novel, potent, oral, small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK) that has selectivity compared with other phosphatidylinositol 3-kinase-related kinase (PIKK) family enzymes. This is a first-time-in-human study, which means that it is the first time the study drug is being used in humans. The purpose of the study is to evaluate the safety and tolerability of single doses of XRD-0394 administered with palliative radiotherapy (RT) to subjects with metastatic, locally advanced, or recurrent cancer. The pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of single-dose XRD-0394 administered in combination with palliative RT will also be characterized.
Detailed description
This is a Phase 1, multicenter, open-label, dose-finding, PK and PD study of XRD-0394 in subjects with metastatic, locally advanced, or recurrent cancer receiving palliative RT. The study will evaluate single-dose PK of XRD-0394 administered to serial cohorts of subjects with the intent of identifying an oral dose that achieves plasma drug concentrations within a specified therapeutic range. Once target plasma concentrations of XRD-0394 are reached, one or more PD cohorts of subjects will be enrolled in order to demonstrate inhibition of radiation-induced ATM activity in tumor biopsy samples from subjects who received the selected dose(s).
Single Dose Escalation: Eligible subjects will be enrolled in serial cohorts to evaluate the PK of single ascending doses of XRD-0394. Dose escalation of XRD-0394 will proceed based on a standard 3+3 design. The starting dose of XRD-0394 will be 40 mg, followed by planned doses of 80 mg and 160 mg. Following administration of a single-dose of XRD-0394 and completion of RT, subjects will be evaluated for the occurrence of dose-limiting toxicities (DLTs). The available PK and safety data for each cohort will be reviewed at the conclusion of the DLT evaluation period before the decision to escalate to the next dose is made. The evaluation of additional doses of XRD-0394 will be determined based on the safety and PK data collected at completed dose levels. Dose escalation may continue until the objectives of the study are met and/or the maximum tolerated dose (MTD) of XRD-0394 is reached. PK samples for measurement of plasma concentrations of XRD-0394 will be collected pre-dose and at specified time points following XRD-0394 administration. Safety and tolerability of each XRD-0394 dose level will be evaluated by assessment of treatment-emergent adverse events (TEAEs), DLTs, and discontinuations due to TEAEs. A Safety Monitoring Committee (SMC) will be used during the study to monitor subject safety and evaluate potential DLTs.
Pharmacodynamic Assessment: The dose identified to produce plasma drug concentrations of XRD-0394 within a targeted therapeutic range will be further evaluated in separate PD cohort(s) of subjects. Subjects enrolled in a PD cohort must have a target tumor with a soft tissue component that is accessible for biopsy and must agree to undergo 1 biopsy during their RT regimen. PK samples for measurement of plasma concentrations of XRD-0394 will be collected from all subjects at pre-dose and at specified time points after XRD-0394 administration. Safety and tolerability of XRD-0394 will be evaluated by assessment of TEAEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XRD-0394 40 mg | Experimental | Drug: XRD-0394, Radiation: Palliative radiotherapySubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen |
| XRD-0394 80 mg | Experimental | Drug: XRD-0394, Radiation: Palliative radiotherapySubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen |
| XRD-0394 160 mg | Experimental | Drug: XRD-0394, Radiation: Palliative radiotherapySubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen |
| XRD-0394 (Dose TBD) | Experimental | Drug: XRD-0394, Radiation: Palliative radiotherapySubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT. A single biopsy will be performed in each subject (either after RT alone or after XRD-0394 and RT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Subjects with locally advanced or recurrent (non-metastatic) cancer for whom palliative RT is indicated may also be enrolled.
- Scheduled to receive palliative RT delivered as 4 Gray × 5 daily fractions at the discretion of the treating radiation oncologist. The radiation plan should be designed to optimally limit the radiation dose delivered to normal tissues using conformal treatment plans and protocol-specified limits.
- One or more of the following sites of metastasis:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Male or female subjects at least 18 years of age who are willing and able to provide written informed consent.
Key exclusion criteria (14 listed)
- Prior radiotherapy to the same region within the last 6 months.
- Subjects who are currently receiving palliative RT for brain metastases. Subjects who have brain metastases may participate in this trial, if they are receiving palliative RT for cancer in a location other than the brain.
- For subjects with cancers involving the spinal cord, the length of the spinal cord requiring palliative treatment must be 10 cm or less.
- Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <0.7 × 10^9/L, or platelets <80 × 10^9/L .
- History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
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 |
|---|---|---|
| XRD-0394Single ascending dose | Drug | XRD-0394 (Dose TBD), XRD-0394 160 mg, XRD-0394 40 mg, XRD-0394 80 mg |
| Palliative radiotherapy4 Gy × 5 daily fractions | Radiation | XRD-0394 (Dose TBD), XRD-0394 160 mg, XRD-0394 40 mg, XRD-0394 80 mg |
Primary outcome
Number of subjects with at least 1 dose-limiting toxicity (DLT)
Time frame: 28 days post-completion of RT
Number of subjects experiencing treatment-emergent adverse events (TEAE), serious TEAEs, TEAEs leading to discontinuation of RT, and TEAEs leading to death
Time frame: 28 days post-completion of RT
8 secondary outcomes
Identification of dose(s) of XRD-0394 that achieve concentrations within protocol-specified range
Time frame: Day 2 of RT regimen
Determination of maximum plasma concentration (Cmax) after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Determination of plasma concentrations at 1 to 4 hours post-dose after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Determination of time to maximum plasma concentration (tmax) after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Determination of area under the plasma concentration versus time curve from zero to the last sampling time (AUC0-t) after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Determination of area under the plasma concentration versus time curve from zero to infinity (AUC0-∞) after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Determination of terminal half-life (t1/2) after a single dose of XRD-0394
Time frame: Day 2 through Day 5 of RT regimen
Change in radiation-induced phosphorylated Krüppel-associated box domain (KRAB)-associated protein 1 (pKAP1) in tumor biopsy samples
Time frame: Day 1 through Day 5 of RT regimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XRD-0394 and Palliative radiotherapy in people with Metastasis and Locally Advanced Solid Tumor, run by XRad Therapeutics Inc at 2 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 9 inclusion and 14 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
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?
Number of subjects with at least 1 dose-limiting toxicity (DLT) (time frame: 28 days post-completion of RT). 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 11 Jan 2024.