Acute Graft-versus-host DiseasePhase 1NCT05673876

A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

A Phase 1 study testing GDC-8264 in people with Acute Graft-versus-host Disease, run by Genentech, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Graft-versus-host Disease
What is being tested?: GDC-8264
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 4 sitesUnited States
Study dates: 6 Apr 2023to 15 Jan 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening
Evidence of engraftment post-transplant
Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening
Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone ≥2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone ≥2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3

Who cannot join

Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse
Prior receipt of more than one allogeneic HSCT
Prior receipt of solid organ transplantation that are target organs for aGVHD (e.g., liver transplant)
Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial
Diagnosis of chronic GVHD or overlap syndrome
Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis)
Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy)
Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
City of Hope National Medical Center
Duarte, California, 91010
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: A Phase Ib, Open-label, Randomized, Dose-finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination With Standard of Care in the Treatment of Acute Graft-versus-Host Disease in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).

Conditions: Acute Graft-versus-host Disease
Being tested: GDC-8264

What participants receive

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

GDC-8264Drug
GDC-8264 tablets will be administered as per the schedule specified in the respective arms.

Study groups in NCT05673876
Study group	Role	What they receive
GDC-8264, 35 mg	Experimental	Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days. Receives: Drug: GDC-8264
GDC-8264, 75 mg	Experimental	Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days. Receives: Drug: GDC-8264

What is being measured

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

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Plasma Concentration of GDC-8264
Plasma concentration of GDC-8264 at specified timepoints was determined.
Measured: Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29
Maximum Plasma Concentration (Cmax) of GDC-8264
Steady-state (SS) PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)
Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)
Terminal Half-life (T1/2) of GDC-8264
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)
Apparent Clearance (CL/F) of GDC-8264
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)
Apparent Volume of Distribution (Vz/F) of GDC-8264
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Measured: Day 1 and SS visit (any time between Day 4 to Day 28)

Secondary outcomes (4)

Overall Response Rate (ORR) on Day 29
ORR=percentage of participants with complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by investigator. CR=all target organs evaluated as Mount Sinai Acute GVHD International Consortium (MAGIC) aGVHD Stage 0 [Skin- no GVHD rash; Liver - bilirubin <2 milligrams/decilitres (mg/dL); Upper gastrointestinal (GI) tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: < 500 mL/day or <3 episodes/day (adults), <10 mL/kilograms (kg)/day or <4 episodes/day]. VGPR=resolution of signs \& symptoms i.e. no rash/residual erythematous rash involving < 25% of body surface, without (w/o) bullae; bilirubin <2 mg/dL or <25% of baseline at screening; toleration of food/enteral feeding; predominantly formed stools; no overt GI bleeding/abdominal cramping; no more than occasional nausea/vomiting. PR=improvement in one/more target organs (skin, liver, upper GI tract, lower GI tract) involved with aGVHD symptoms w/o worsening in others.
Measured: Up to Day 29
Duration of Response (DOR)
DOR was defined astime from response (CR, VGPR or PR) on Day 29 to aGVHD progression from nadir in any organ, new systemic therapy for aGVHD, or death from any cause (whichever occurs first), as determined by the investigator. CR=all target organs evaluated as MAGIC aGVHD Stage 0 [Skin- no GVHD rash; Liver - bilirubin <2 mg/dL; Upper GI tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: < 500 mL/day or <3 episodes/day (adults), <10 mL/kg/day or <4 episodes/day]. VGPR=resolution of signs \& symptoms i.e. no rash or residual erythematous rash involving < 25% of body surface, without bullae; bilirubin <2 mg/dL or <25% of baseline at screening; toleration of food/enteral feeding; predominantly formed stools; no overt GI bleeding or abdominal cramping; no more than occasional nausea or vomiting. PR=improvement in one or more target organs (skin, liver, upper GI tract, lower GI tract) involved with aGVHD symptoms without worsening in others.
Measured: From Day 29 up to end of study (up to 9 months)
Percentage of Participants With aGVHD Flares by Day 56
aGVHD flare was defined as an increase in aGVHD target organ stage by at least one stage for at least 3 days that requires either addition of a new line of systemic treatment or increase in corticosteroid dose > 0.25 mg/kg/day.
Measured: Baseline up to Day 56
Percentage of Participants With Non-relapse Mortality (NRM) by Day 180
NRM was defined as any death that occurred after onset of aGVHD that was not attributable to relapse of the underlying primary disease was considered a non-relapse death.
Measured: Baseline up to Day 180

Timeline

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

6 Apr 202315 Jan 2024

First posted6 Jan 2023
Study start6 Apr 2023
Primary completion15 Jan 2024
Study completion15 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05673876
Sponsor's protocol ID: GA43861
Other IDs: ISRCTN27200385
Status last verified: May 2025
First submitted: 21 Dec 2022
Last updated: 28 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Open-label, Randomized, Dose-finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination With Standard of Care in the Treatment of Acute Graft-versus-Host Disease in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05673876
Acronym / sponsor ID: GA43861
Conditions: Acute Graft-versus-host Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 6 Apr 2023 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 15 Jan 2024 (actual)
First posted: 6 Jan 2023 (actual)
Results: Posted 24 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GDC-8264, 35 mg	Experimental	Drug: GDC-8264Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days.
GDC-8264, 75 mg	Experimental	Drug: GDC-8264Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days.

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening
Evidence of engraftment post-transplant
Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening
Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone ≥2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone ≥2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3

Key exclusion criteria (8 listed)

Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse
Prior receipt of more than one allogeneic HSCT
Prior receipt of solid organ transplantation that are target organs for aGVHD (e.g., liver transplant)
Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial
Diagnosis of chronic GVHD or overlap syndrome

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
GDC-8264GDC-8264 tablets will be administered as per the schedule specified in the respective arms.	Drug	GDC-8264, 35 mg, GDC-8264, 75 mg

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Plasma Concentration of GDC-8264
Time frame: Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29
Plasma concentration of GDC-8264 at specified timepoints was determined.
Maximum Plasma Concentration (Cmax) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
Steady-state (SS) PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Terminal Half-life (T1/2) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Apparent Clearance (CL/F) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Apparent Volume of Distribution (Vz/F) of GDC-8264
Time frame: Day 1 and SS visit (any time between Day 4 to Day 28)
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.

4 secondary outcomes

Overall Response Rate (ORR) on Day 29
Time frame: Up to Day 29
Duration of Response (DOR)
Time frame: From Day 29 up to end of study (up to 9 months)
Percentage of Participants With aGVHD Flares by Day 56
Time frame: Baseline up to Day 56
Percentage of Participants With Non-relapse Mortality (NRM) by Day 180
Time frame: Baseline up to Day 180

Results and safety

Results posted to the registry on 24 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GDC-8264 35 mg	4	1
GDC-8264 75 mg	3	0

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months). Count of participants. Unit: Participants

Measure	GDC-8264 35 mg n = 4	GDC-8264 75 mg n = 3
Value	4	3

Population analysed: Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.

Primary outcome: Plasma Concentration of GDC-8264

Time frame: Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/millilitres (ng/mL)

Measure	GDC-8264 35 mg n = 3	GDC-8264 75 mg n = 3
Predose on Day 1	NA (NA)	NA (NA)
1.5 hours Postdose on Day 1	28.3 (141.5)	698 (17.0)
2 hours Postdose on Day 1	151 (NA)	835 (10.3)
3 hours Postdose on Day 1	89.7 (321.6)	858 (57.2)
4 hours Postdose on Day 1	123 (141.1)	781 (33.8)
6 hours Postdose on Day 1	227 (NA)	700 (52.5)
12 hours Postdose on Day 1	24.0 (28439.7)	361 (106.5)
24 hours Postdose on Day 1	12.2 (5241.5)	144 (116.0)

Population analysed: Pharmacokinetic (PK) population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Primary outcome: Maximum Plasma Concentration (Cmax) of GDC-8264

Time frame: Day 1 and SS visit (any time between Day 4 to Day 28). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	GDC-8264 35 mg n = 3	GDC-8264 75 mg n = 2
Day 1	270.00 (NA)	991.21 (33.7)
SS PK Day	541.48 (31.1)	1480.00 (NA)

Population analysed: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Primary outcome: Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264

Time frame: Day 1 and SS visit (any time between Day 4 to Day 28). Median (Full Range). Unit: hours

Measure	GDC-8264 35 mg n = 3	GDC-8264 75 mg n = 2
Day 1	3.4 (3.4 to 3.4)	2.30 (1.6 to 3.0)
SS PK Day	2.17 (1.5 to 3.1)	3.2 (3.2 to 3.2)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GDC-8264 35mg	4 of 4 (100%)	4 of 4 (100%)	3 of 4
GDC-8264 75mg	3 of 3 (100%)	3 of 3 (100%)	2 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

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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.

Clinical Trials study director

Hoffmann-La Roche

4 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 GDC-8264 in people with Acute Graft-versus-host Disease, run by Genentech, Inc. at 4 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 4 inclusion and 8 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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With Adverse Events (AEs) (time frame: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)). The study lists 8 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 NCT05673876.

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 28 May 2025.