Solid TumorsPhase 1NCT05996445
A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1 study testing XmAb662 and Keytruda® (pembrolizumab) in people with Solid Tumors, run by Xencor, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- XmAb662 and Keytruda® (pembrolizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jul 2023to 21 May 2024
- 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
- Advanced, recurrent or metastatic solid malignancy that is not amenable to curative-intent treatment and which has progressed after standard therapy appropriate for the following tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer, small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, breast cancer, ovarian cancer (epithelial), castration-resistant prostate cancer (adenocarcinoma)
- Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For dose escalation cohorts, subjects must have adequate archival tumor sample or willing to provide a fresh tumor
- Adequate organ function
Who cannot join
- Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug; other anticancer therapies, including chemotherapy or radiation therapy, given within 4 weeks of the start of study drug (palliative radiation given within a 1-week washout is allowed)
- History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy
- History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to prior immunotherapy or any prior irAE, regardless of grade
- History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy
- Known active central nervous system involvement by malignant disease; subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
- For subjects receiving pembrolizumab, prior Grade 3 or Grade 4 infusion-related reactions to pembrolizumab, or known hypersensitivity to pembrolizumab
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662.
Read the detailed description
This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standard/approved therapies, or for which there are no effective available therapies. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662 monotherapy and XmAb662+pembrolizumab combination.
- Conditions
- Solid Tumors
- Being tested
- XmAb662, Keytruda® (pembrolizumab)
- Keywords
- IL-12,, interleukin-12, pembrolizumab, Advanced Solid Tumors, Metastatic Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb662Biological
Intravenous (IV) administration
Keytruda® (pembrolizumab)Biological
Intravenous (IV) administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion XmAb662 administered as monotherapy | Experimental | Not described Receives: Biological: XmAb662 |
| Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab | Experimental | Not described Receives: Biological: XmAb662; Biological: Keytruda® (pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)
Measured: First 3 weeks on treatment for each subject]
Incidence and severity of treatment emergent adverse events (TEAEs)
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
Measured: Up to 2 years
Secondary outcomes (5)
Characterization of pharmacokinetics
Measurement of Cmax
Measured: 56 Days
Characterization of pharmacokinetics
Measurement of AUC
Measured: 56 Days
Objective response rate
Objective response rate by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
Measured: Up to 2 years
Progression-free survival
Progression-free survival by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
Measured: Up to 2 years
Duration of response
Duration of response by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start28 Jul 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Why it stopped: The Sponsor made a business decision to end the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Model description
- Sequential Assignments
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chet Bohac, MD, Study director, Executive Medical Director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996445
- Sponsor's protocol ID
- XmAb662-01
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05996445
- Acronym / sponsor ID
- XmAb662-01
- Conditions
- Solid Tumors
- Keywords
- IL-12,, interleukin-12, pembrolizumab, Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor made a business decision to end the study.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 18 Aug 2023 (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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662.
Detailed description
This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standard/approved therapies, or for which there are no effective available therapies. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662 monotherapy and XmAb662+pembrolizumab combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Assignments
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion XmAb662 administered as monotherapy | Experimental | Biological: XmAb662 |
| Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab | Experimental | Biological: XmAb662, Biological: Keytruda® (pembrolizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced, recurrent or metastatic solid malignancy that is not amenable to curative-intent treatment and which has progressed after standard therapy appropriate for the following tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer, small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, breast cancer, ovarian cancer (epithelial), castration-resistant prostate cancer (adenocarcinoma)
- Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For dose escalation cohorts, subjects must have adequate archival tumor sample or willing to provide a fresh tumor
Key exclusion criteria (7 listed)
- Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug; other anticancer therapies, including chemotherapy or radiation therapy, given within 4 weeks of the start of study drug (palliative radiation given within a 1-week washout is allowed)
- History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy
- History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to prior immunotherapy or any prior irAE, regardless of grade
- History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy
- Known active central nervous system involvement by malignant disease; subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
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 |
|---|---|---|
| XmAb662Intravenous (IV) administration | Biological | Dose Escalation and Expansion XmAb662 administered as monotherapy, Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab |
| Keytruda® (pembrolizumab)Intravenous (IV) administration | Biological | Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: First 3 weeks on treatment for each subject]
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 2 years
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
5 secondary outcomes
Characterization of pharmacokinetics
Time frame: 56 Days
Characterization of pharmacokinetics
Time frame: 56 Days
Objective response rate
Time frame: Up to 2 years
Progression-free survival
Time frame: Up to 2 years
Duration of response
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: The Sponsor made a business decision to end the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Chet Bohac, MD study director
Executive Medical Director, Clinical Development
3 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 XmAb662 and Keytruda® (pembrolizumab) in people with Solid Tumors, run by Xencor, Inc. at 3 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 6 inclusion and 7 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 23 Aug 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 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 was stopped early (reason given: The Sponsor made a business decision to end the study.). 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?
Incidence of dose-limiting toxicities (DLTs) (time frame: First 3 weeks on treatment for each subject]). 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 23 Aug 2024.