Phase 1 Clinical Trials

By conducting phase 1 trials, we play a key role in helping to advance research, potentially offering early access to cutting-edge treatments, while developing more effective therapies for the future.

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A critical component of our commitment to bring innovative therapies to patients

Phase 1 clinical trials are the first step in testing new treatments in people. These studies focus on safety, dosage, and how the body processes new drugs or therapies. They are essential for bringing innovative treatments to patients who may have limited options.

  • Purpose: Assess safety, determine the best dose, and monitor side effects.
  • Participants: Small groups (20–100), often patients with advanced conditions or healthy volunteers.
  • Process: Participants are closely monitored in a controlled environment.
  • Duration: Trials may last days, weeks, or longer, with required follow-up visits.
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Let us help you determine if a phase 1 clinical trial is right for you. Contact our research team today.

Blood cancer trials

Review phase 1 clinical trials for blood cancers.

A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation.
Study details
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.
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.
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.

Cancer (solid tumor) trials

Review phase 1 clinical trials for solid tumor cancers.

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.

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.

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.

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.

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.

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.

Autoimmune disease trials

Review phase 1 clinical trials for autoimmune diseases.

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).

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).
A Phase 1b, Open-label, Study of CLN-978 for the Treatment of Active Moderate to Severe Sjogren’s Disease (SjD).
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).
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Benefits and risks of participating

While phase 1 trials may offer direct benefits benefits, they also carry risks. Here are some benefits and risks of participating in a phase 1 clinical trial for you to consider:

Benefits

  • Early access to new treatments not available to the public.
  • Personalized, attentive care from experienced medical professionals.
  • Contribute to research and help future patients.

Risks

  • Unknown side effects—these are the first human tests.
  • No guaranteed benefit—the main goal is safety, not effectiveness.
  • Time commitment—frequent visits and follow-ups may be required.

Frequently asked questions

Here are some common FAQs about phase 1 clinical trials.

  • Phase 1: Safety and dosage (20–100 participants)
  • Phase 2: Effectiveness and side effects (100–300 participants)
  • Phase 3: Comparison to standard treatments (1,000–3,000 participants)
  • Phase 4: Long-term monitoring after approval
The main goal is to test the safety of a new drug or treatment. Researchers want to find out the best dose, how the drug behaves in the body, and identify any side effects.
Eligibility depends on the specific trial. Most phase 1 trials enroll adults with advanced conditions, but some include healthy volunteers.
Yes. Side effects are often unknown and can be serious. All participants are closely monitored, and you can withdraw at any time.
There is no guarantee of personal benefit, but you may access new treatments before they are widely available.
These trials can be short, lasting a few days, or extend to several weeks or years. They may require follow-up visits after the initial testing phase.
Many phase 1 trials offer reimbursement for food, travel, and lodging, though the amount varies depending on the trial.
Phase 1 trials are conducted in a specialized clinical research unit at Intermountain LDS Hospital where you are closely monitored.
As a clinical trial participant, you are closely monitored for side effects, and if any occur, you may receive medical attention. The trial team will also adjust dosages or stop the trial if necessary.
Yes, participation in clinical trials is always voluntary, and you can withdraw from the study at any time without penalty.

Each trial has specific criteria. Our research team will guide you through the screening process.

If you have any other questions or concerns about phase 1 clinical trials, please email our research team.

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