Phase I Clinical Trials
If you’re living with an advanced or hard‑to‑treat cancer, Phase I clinical trials may offer access to new treatment options not yet widely available.
Explore new possibilities through Phase I cancer clinical trials
If standard cancer treatments are no longer working or you've been diagnosed with an advanced cancer, a Phase I clinical trial may provide access to promising new therapies before they become widely available.
Intermountain's Phase I Clinical Trials Program connects patients with innovative cancer research studies and a team of specialists who guide every step of the process, from eligibility screening through ongoing care.
Advanced research with patient‑centered care
Understanding your cancer risk can feel overwhelming, but you don't have to navigate it alone. Our specialists combine genetic expertise, personalized prevention strategies, and advanced screening recommendations to help you take proactive steps for your health.
What are Phase I clinical trials?
Phase I clinical trials are the first studies that test a new treatment in people. Researchers use these studies to understand how a treatment works, identify possible side effects, and determine safe dosage levels. Many Phase I studies evaluate new cancer therapies, including targeted treatments, immunotherapies, and cellular therapies.
While these trials are not designed to cure cancer, they help advance cancer treatment and may provide additional options for patients whose cancer has not responded to standard therapies.
Who may qualify for a Phase I clinical trial?
Every clinical trial has specific eligibility requirements designed to protect patients and ensure reliable research results. Eligibility may depend on:
- Cancer type
- Cancer stage
- Previous treatments
- Overall health
- Genetic or molecular tumor markers
Our team can review your information and help determine whether a clinical trial may be appropriate.
Featured Phase I Clinical Trials
Below are examples of Phase I trials currently available through our program.
- Acute Leukemia - A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation.
- Acute Myeloid Leukemia - Acute Leukemia A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes.
- Lower-risk Myelodysplastic Syndromes - An Open-label, Phase 1b Study of R289, an IRAK1/4 Inhibitor, in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) Who Are Relapsed/Refractory/Resistant to Prior Therapies. [Study details]
- Non Hodgkin Lymphoma -A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of IMPT-314, a CD19/20 Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma.
- Idiopathic Inflammatory Myopathy
- A phase 1 study evaluating the safety and preliminary efficacy of ALLO-329, a dual anti-CD19/anti-CD70 allogeneic CAR T Cell product in autoimmune disease. [Study details]
- A phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies. [Study details]
- Lupus Nephritis - A Phase 2, adaptive, randomized, open-label, assessor blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). [Study details]
- Myasthenia Gravis - A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6). [Study details]
- Systemic Lupus Erythematosus (SLE)
- A Phase 1b, open-label, pilot study of CLN-978 for the treatment of moderate to severe Systemic Lupus Erythematosus (SLE). [Study details]
- A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease. [Study details]
- Sjogren's Disease (SjD) - A Phase 1b, Open-label, Study of CLN-978 for the Treatment of Active Moderate to Severe Sjogren’s Disease (SjD). [Study details]
- Systemic Sclerosis - A phase 1 study evaluating the safety and preliminary efficacy of ALLO-329, a dual anti-CD19/anti-CD70 allogeneic CAR T Cell product in autoimmune disease. [Study details]
- Systemic Sclerosis - A phase 2, multi-part, three-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis. [Study details]
- Vasculitis - A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA). [Study details]
- Gastrointestinal Cancer - A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
- Gastrointestinal Cancer - A phase 1, open-label, dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors. [Study details]
- Breast Cancer
- A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
- A phase 1, open-label, dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors. [Study details]
- Gynecological Cancer
- A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
- A phase 1, open-label, dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors. [Study details]
- A phase 1a/1b Study of 27T51, an anti-MUC16 CAR-T cell drug product administered alone or in combination for participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. [Study details]
- Lung Cancer
- A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
- A phase 1, open-label, dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors. [Study details]
- Triple-negative Breast Cancer (TNBC) - A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
- Other solid tumors - A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 DEGRADER NKT3964 in adults with advanced/metastatic solid tumors. [Study details]
Browse all active clinical trials
Common questions about Phase I cancer clinical trials
Answers to common questions about early phase cancer trials, eligibility, and how to take the next step.
Eligibility depends on the specific trial. Most phase I trials enroll adults with advanced conditions, but some include healthy volunteers.
The easiest way to get started is to contact our Phase I trials team by email. We’ll guide you through screening and answer your questions.
While phase I trials may offer direct benefits benefits, they also carry risks. Here are some benefits and risks of participating in a phase I clinical trial for you to consider:
Benefits
- There is no guarantee of personal benefit, but you may access new treatments before they are widely available.
- Personalized, attentive care from experienced medical professionals.
- Contribute to research and help future patients.
Risks
- Side effects are often unknown and can be serious. All participants are closely monitored, and you can withdraw at any time.
- No guaranteed benefit—the main goal is safety, not effectiveness.
- Time commitment—frequent visits and follow-ups may be required.
Phase I trials are conducted in a specialized clinical research unit at Intermountain LDS Hospital where patients are closely monitored.
Access to Phase I clinical trials and oncology research trials if offered across Utah, Idaho, Nevada, Colorado, Wyoming and Montana. Patients searching for Phase I trials near me or cancer clinical trials near me can begin by contacting our central research team, who will help guide location and next steps.
- Phase I: Safety and dosage (20–100 participants)
- Phase II: Effectiveness and side effects (100–300 participants)
- Phase III: Comparison to standard treatments (1,000–3,000 participants)
- Phase IV: Long-term monitoring after approval